The Official Patient's Sourcebook on Kaposi's Sarcoma: A Revised and Updated Directory for the Internet Age

THE OFFICIAL PATIENT’S SOURCEBOOK on J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS ii ICON H...

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THE OFFICIAL PATIENT’S SOURCEBOOK

on

J AMES N. P ARKER , M.D. AND P HILIP M. P ARKER , P H .D., E DITORS

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ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright Ó2003 by ICON Group International, Inc. Copyright Ó2003 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1

Publisher, Health Care: Tiffany LaRochelle Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher’s note: The ideas, procedures, and suggestions contained in this book are not intended as a substitute for consultation with your physician. All matters regarding your health require medical supervision. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation, in close consultation with a qualified physician. The reader is advised to always check product information (package inserts) for changes and new information regarding dose and contraindications before taking any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961Parker, Philip M., 1960The Official Patient’s Sourcebook on Kaposi’s Sarcoma: A Revised and Updated Directory for the Internet Age/James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary and index. ISBN: 0-597-83528-4 1. Kaposi’s Sarcoma-Popular works. I. Title.

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Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem or as a substitute for consultation with licensed medical professionals. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors or authors. ICON Group International, Inc., the editors, or the authors are not responsible for the content of any Web pages nor publications referenced in this publication.

Copyright Notice If a physician wishes to copy limited passages from this sourcebook for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications are copyrighted. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs or other materials, please contact us to request permission (e-mail: [email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this sourcebook.

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Dedication To the healthcare professionals dedicating their time and efforts to the study of Kaposi’s sarcoma.

Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this sourcebook which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which directly or indirectly are dedicated to Kaposi’s sarcoma. All of the Official Patient’s Sourcebooks draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this sourcebook. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany LaRochelle for her excellent editorial support.

Contents

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About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for the Official Patient’s Sourcebook series published by ICON Health Publications.

Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for the Official Patient’s Sourcebook series published by ICON Health Publications.

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About ICON Health Publications In addition to Kaposi’s sarcoma, Official Patient’s Sourcebooks are available for the following related topics: ·

The Official Patient's Sourcebook on Aids-Related Lymphoma

To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes & Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341

Contents vii

Table of Contents INTRODUCTION...................................................................................... 1

Overview............................................................................................................... 1 Organization......................................................................................................... 3 Scope ..................................................................................................................... 3 Moving Forward................................................................................................... 4

PART I: THE ESSENTIALS ................................................. 7 CHAPTER 1. THE ESSENTIALS ON KAPOSI’S SARCOMA: GUIDELINES .. 9

Overview............................................................................................................... 9 What Is Kaposi’s Sarcoma? ................................................................................ 11 Types of Kaposi’s Sarcoma.................................................................................. 12 How Kaposi’s Sarcoma Is Treated ...................................................................... 13 Treatment by Type.............................................................................................. 14 Classic Kaposi’s Sarcoma.................................................................................... 14 Immunosuppressive Treatment Related-Kaposi’s Sarcoma ............................... 15 Epidemic Kaposi’s Sarcoma ................................................................................ 15 Recurrent Kaposi’s Sarcoma............................................................................... 15 To Learn More .................................................................................................... 15 About PDQ......................................................................................................... 17 More Guideline Sources ..................................................................................... 18 Vocabulary Builder............................................................................................. 23

CHAPTER 2. SEEKING GUIDANCE ....................................................... 25

Overview............................................................................................................. 25 Associations and Kaposi’s Sarcoma.................................................................... 25 Finding More Associations................................................................................. 26 Cancer Support Groups...................................................................................... 27 The Cancer Information Service ......................................................................... 29 Finding Cancer Resources in Your Community................................................ 32 Finding Doctors Who Specialize in Cancer Care ............................................... 35 Selecting Your Doctor ........................................................................................ 38 Working with Your Doctor ................................................................................ 39 Finding a Cancer Treatment Facility ................................................................. 40 Additional Cancer Support Information ............................................................ 42 Vocabulary Builder............................................................................................. 42

CHAPTER 3. CLINICAL TRIALS AND KAPOSI’S SARCOMA .................. 45

Overview............................................................................................................. 45 Recent Trials on Kaposi’s Sarcoma .................................................................... 48 Benefits and Risks............................................................................................... 80 Clinical Trials and Insurance Coverage ............................................................. 83 What Costs Do Trials Involve? .......................................................................... 83 Clinical Trials and Medicare Coverage .............................................................. 86

viii Contents

Increasing the Likelihood of Insurance Coverage for Trials ............................... 87 What If An Insurance Claim Is Denied after the Trial Has Begun?.................. 89 Where Else Can I Turn for Assistance? ............................................................. 89 Government Initiatives to Expand Insurance Coverage for Trials .................... 92 Keeping Current on Clinical Trials.................................................................... 93 General References.............................................................................................. 94 Vocabulary Builder............................................................................................. 95

PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL................................................ 101 CHAPTER 4. STUDIES ON KAPOSI’S SARCOMA.................................. 103

Overview........................................................................................................... 103 The Combined Health Information Database ................................................... 103 Federally Funded Research on Kaposi’s Sarcoma............................................. 104 E-Journals: PubMed Central ............................................................................ 113 The National Library of Medicine: PubMed .................................................... 114 Vocabulary Builder........................................................................................... 127

CHAPTER 5. BOOKS ON KAPOSI’S SARCOMA .................................... 131

Overview........................................................................................................... 131 Book Summaries: Federal Agencies .................................................................. 131 The National Library of Medicine Book Index ................................................. 132 Chapters on Kaposi’s Sarcoma.......................................................................... 134 General Home References ................................................................................. 136 Vocabulary Builder........................................................................................... 137

CHAPTER 6. MULTIMEDIA ON KAPOSI’S SARCOMA ......................... 139

Overview........................................................................................................... 139 Bibliography: Multimedia on Kaposi’s Sarcoma .............................................. 139 Vocabulary Builder........................................................................................... 140

CHAPTER 7. PHYSICIAN GUIDELINES AND DATABASES ................... 141

Overview........................................................................................................... 141 NIH Guidelines................................................................................................. 141 What Is Kaposi’s Sarcoma? .............................................................................. 142 Stage Information ............................................................................................. 146 Classic Kaposi’s Sarcoma.................................................................................. 148 Standard Treatment Options for Solitary Lesions ........................................... 148 Standard Treatment Options for Widespread Skin Disease............................. 149 Treatment for Lymph Node and Gastrointestinal Tract Involvement ............. 151 Immunosuppressive Treatment-Related Kaposi’s Sarcoma ............................. 151 Epidemic Kaposi’s Sarcoma .............................................................................. 152 Treatment Options under Clinical Evaluation ................................................ 156 NIH Databases.................................................................................................. 156 Other Commercial Databases ........................................................................... 160 The Genome Project and Kaposi’s Sarcoma ..................................................... 160

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Specialized References....................................................................................... 165 Vocabulary Builder........................................................................................... 166

CHAPTER 8. DISSERTATIONS ON KAPOSI’S SARCOMA ..................... 167

Overview........................................................................................................... 167 Dissertations on Kaposi’s Sarcoma .................................................................. 167 Keeping Current ............................................................................................... 168

PART III. APPENDICES .................................................. 169 APPENDIX A. RESEARCHING YOUR MEDICATIONS.......................... 171

Overview........................................................................................................... 171 Your Medications: The Basics .......................................................................... 171 Learning More about Your Medications .......................................................... 173 Commercial Databases...................................................................................... 177 Drug Development and Approval .................................................................... 178 Understanding the Approval Process for New Cancer Drugs......................... 179 The Role of the Federal Drug Administration (FDA)...................................... 180 Getting Drugs to Patients Who Need Them .................................................... 183 Researching Orphan Drugs.............................................................................. 185 Contraindications and Interactions (Hidden Dangers) ................................... 187 A Final Warning .............................................................................................. 188 General References............................................................................................ 188 Vocabulary Builder........................................................................................... 189

APPENDIX B. RESEARCHING ALTERNATIVE MEDICINE ................... 191

Overview........................................................................................................... 191 What Is CAM? ................................................................................................. 192 What Are the Domains of Alternative Medicine?............................................ 193 Finding CAM References on Kaposi’s Sarcoma............................................... 198 Additional Web Resources................................................................................ 199 General References............................................................................................ 201 Vocabulary Builder........................................................................................... 202

APPENDIX C. RESEARCHING NUTRITION ......................................... 205

Overview........................................................................................................... 205 Food and Nutrition: General Principles........................................................... 205 Finding Studies on Kaposi’s Sarcoma .............................................................. 210 Federal Resources on Nutrition........................................................................ 211 Additional Web Resources................................................................................ 212 Vocabulary Builder........................................................................................... 212

APPENDIX D. FINDING MEDICAL LIBRARIES.................................... 215

Overview........................................................................................................... 215 Preparation ....................................................................................................... 215 Finding a Local Medical Library ...................................................................... 216 Medical Libraries Open to the Public............................................................... 216

APPENDIX E. YOUR RIGHTS AND INSURANCE ................................. 223

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Overview........................................................................................................... 223 Your Rights as a Patient................................................................................... 223 Patient Responsibilities .................................................................................... 227 Choosing an Insurance Plan............................................................................. 228 Medicare and Medicaid .................................................................................... 230 Financial Assistance for Cancer Care............................................................... 233 NORD’s Medication Assistance Programs ..................................................... 236 Additional Resources ........................................................................................ 236 Vocabulary Builder........................................................................................... 237

ONLINE GLOSSARIES.................................................... 239 Online Dictionary Directories.......................................................................... 242

KAPOSI’S SARCOMA GLOSSARY ............................. 243 General Dictionaries and Glossaries ................................................................ 256

INDEX................................................................................... 259

Introduction

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INTRODUCTION Overview Dr. C. Everett Koop, former U.S. Surgeon General, once said, “The best prescription is knowledge.”1 The Agency for Healthcare Research and Quality (AHRQ) of the National Institutes of Health (NIH) echoes this view and recommends that every patient incorporate education into the treatment process. According to the AHRQ: Finding out more about your condition is a good place to start. By contacting groups that support your condition, visiting your local library, and searching on the Internet, you can find good information to help guide your treatment decisions. Some information may be hard to find—especially if you don’t know where to look.2 As the AHRQ mentions, finding the right information is not an obvious task. Though many physicians and public officials had thought that the emergence of the Internet would do much to assist patients in obtaining reliable information, in March 2001 the National Institutes of Health issued the following warning: The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading.3

Quotation from http://www.drkoop.com. The Agency for Healthcare Research and Quality (AHRQ): http://www.ahcpr.gov/consumer/diaginfo.htm. 3 Adapted from the NIH, National Cancer Institute (NCI): http://cancertrials.nci.nih.gov/beyond/evaluating.html. 1 2

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Kaposi’s Sarcoma

Since the late 1990s, physicians have seen a general increase in patient Internet usage rates. Patients frequently enter their doctor’s offices with printed Web pages of home remedies in the guise of latest medical research. This scenario is so common that doctors often spend more time dispelling misleading information than guiding patients through sound therapies. The Official Patient’s Sourcebook on Kaposi’s Sarcoma has been created for patients who have decided to make education and research an integral part of the treatment process. The pages that follow will tell you where and how to look for information covering virtually all topics related to Kaposi’s sarcoma, from the essentials to the most advanced areas of research. The title of this book includes the word “official.” This reflects the fact that the sourcebook draws from public, academic, government, and peerreviewed research. Selected readings from various agencies are reproduced to give you some of the latest official information available to date on Kaposi’s sarcoma. Given patients’ increasing sophistication in using the Internet, abundant references to reliable Internet-based resources are provided throughout this sourcebook. Where possible, guidance is provided on how to obtain free-ofcharge, primary research results as well as more detailed information via the Internet. E-book and electronic versions of this sourcebook are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). Hard copy users of this sourcebook can type cited Web addresses directly into their browsers to obtain access to the corresponding sites. Since we are working with ICON Health Publications, hard copy Sourcebooks are frequently updated and printed on demand to ensure that the information provided is current. In addition to extensive references accessible via the Internet, every chapter presents a “Vocabulary Builder.” Many health guides offer glossaries of technical or uncommon terms in an appendix. In editing this sourcebook, we have decided to place a smaller glossary within each chapter that covers terms used in that chapter. Given the technical nature of some chapters, you may need to revisit many sections. Building one’s vocabulary of medical terms in such a gradual manner has been shown to improve the learning process. We must emphasize that no sourcebook on Kaposi’s sarcoma should affirm that a specific diagnostic procedure or treatment discussed in a research study, patent, or doctoral dissertation is “correct” or your best option. This sourcebook is no exception. Each patient is unique. Deciding on appropriate

Introduction

3

options is always up to the patient in consultation with their physician and healthcare providers.

Organization This sourcebook is organized into three parts. Part I explores basic techniques to researching Kaposi’s sarcoma (e.g. finding guidelines on diagnosis, treatments, and prognosis), followed by a number of topics, including information on how to get in touch with organizations, associations, or other patient networks dedicated to Kaposi’s sarcoma. It also gives you sources of information that can help you find a doctor in your local area specializing in treating Kaposi’s sarcoma. Collectively, the material presented in Part I is a complete primer on basic research topics for patients with Kaposi’s sarcoma. Part II moves on to advanced research dedicated to Kaposi’s sarcoma. Part II is intended for those willing to invest many hours of hard work and study. It is here that we direct you to the latest scientific and applied research on Kaposi’s sarcoma. When possible, contact names, links via the Internet, and summaries are provided. It is in Part II where the vocabulary process becomes important as authors publishing advanced research frequently use highly specialized language. In general, every attempt is made to recommend “free-to-use” options. Part III provides appendices of useful background reading for all patients with Kaposi’s sarcoma or related disorders. The appendices are dedicated to more pragmatic issues faced by many patients with Kaposi’s sarcoma. Accessing materials via medical libraries may be the only option for some readers, so a guide is provided for finding local medical libraries which are open to the public. Part III, therefore, focuses on advice that goes beyond the biological and scientific issues facing patients with Kaposi’s sarcoma.

Scope While this sourcebook covers Kaposi’s sarcoma, your doctor, research publications, and specialists may refer to your condition using a variety of terms. Therefore, you should understand that Kaposi’s sarcoma is often considered a synonym or a condition closely related to the following: ·

Endotheliosarcoma

·

Multiple, Idiopathic Hemorrhagic Sarcoma

4

Kaposi’s Sarcoma

In addition to synonyms and related conditions, physicians may refer to Kaposi’s sarcoma using certain coding systems. The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) is the most commonly used system of classification for the world’s illnesses. Your physician may use this coding system as an administrative or tracking tool. The following classification is commonly used for Kaposi’s sarcoma:4 ·

173.9 malignant neoplasm of the skin

For the purposes of this sourcebook, we have attempted to be as inclusive as possible, looking for official information for all of the synonyms relevant to Kaposi’s sarcoma. You may find it useful to refer to synonyms when accessing databases or interacting with healthcare professionals and medical librarians.

Moving Forward Since the 1980s, the world has seen a proliferation of healthcare guides covering most illnesses. Some are written by patients or their family members. These generally take a layperson’s approach to understanding and coping with an illness or disorder. They can be uplifting, encouraging, and highly supportive. Other guides are authored by physicians or other healthcare providers who have a more clinical outlook. Each of these two styles of guide has its purpose and can be quite useful. As editors, we have chosen a third route. We have chosen to expose you to as many sources of official and peer-reviewed information as practical, for the purpose of educating you about basic and advanced knowledge as recognized by medical science today. You can think of this sourcebook as your personal Internet age reference librarian. Why “Internet age”? All too often, patients diagnosed with Kaposi’s sarcoma will log on to the Internet, type words into a search engine, and receive several Web site listings which are mostly irrelevant or redundant. These patients are left to wonder where the relevant information is, and how to obtain it. Since only the smallest fraction of information dealing with This list is based on the official version of the World Health Organization’s 9th Revision, International Classification of Diseases (ICD-9). According to the National Technical Information Service, “ICD-9CM extensions, interpretations, modifications, addenda, or errata other than those approved by the U.S. Public Health Service and the Health Care Financing Administration are not to be considered official and should not be utilized. Continuous maintenance of the ICD-9-CM is the responsibility of the federal government.”

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Introduction

5

Kaposi’s sarcoma is even indexed in search engines, a non-systematic approach often leads to frustration and disappointment. With this sourcebook, we hope to direct you to the information you need that you would not likely find using popular Web directories. Beyond Web listings, in many cases we will reproduce brief summaries or abstracts of available reference materials. These abstracts often contain distilled information on topics of discussion. While we focus on the more scientific aspects of Kaposi’s sarcoma, there is, of course, the emotional side to consider. Later in the sourcebook, we provide a chapter dedicated to helping you find peer groups and associations that can provide additional support beyond research produced by medical science. We hope that the choices we have made give you the most options available in moving forward. In this way, we wish you the best in your efforts to incorporate this educational approach into your treatment plan. The Editors

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PART I: THE ESSENTIALS

ABOUT PART I Part I has been edited to give you access to what we feel are “the essentials” on Kaposi’s sarcoma. The essentials of a disease typically include the definition or description of the disease, a discussion of who it affects, the signs or symptoms associated with the disease, tests or diagnostic procedures that might be specific to the disease, and treatments for the disease. Your doctor or healthcare provider may have already explained the essentials of Kaposi’s sarcoma to you or even given you a pamphlet or brochure describing Kaposi’s sarcoma. Now you are searching for more indepth information. As editors, we have decided, nevertheless, to include a discussion on where to find essential information that can complement what your doctor has already told you. In this section we recommend a process, not a particular Web site or reference book. The process ensures that, as you search the Web, you gain background information in such a way as to maximize your understanding.

Guidelines

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CHAPTER 1. THE ESSENTIALS ON KAPOSI’S SARCOMA: GUIDELINES Overview Official agencies, as well as federally funded institutions supported by national grants, frequently publish a variety of guidelines on Kaposi’s sarcoma. These are typically called “Fact Sheets” or “Guidelines.” They can take the form of a brochure, information kit, pamphlet, or flyer. Often they are only a few pages in length. The great advantage of guidelines over other sources is that they are often written with the patient in mind. Since new guidelines on Kaposi’s sarcoma can appear at any moment and be published by a number of sources, the best approach to finding guidelines is to systematically scan the Internet-based services that post them.

The National Institutes of Health (NIH)5 The National Institutes of Health (NIH) is the first place to search for relatively current patient guidelines and fact sheets on Kaposi’s sarcoma. Originally founded in 1887, the NIH is one of the world’s foremost medical research centers and the federal focal point for medical research in the United States. At any given time, the NIH supports some 35,000 research grants at universities, medical schools, and other research and training institutions, both nationally and internationally. The rosters of those who have conducted research or who have received NIH support over the years include the world’s most illustrious scientists and physicians. Among them are 97 scientists who have won the Nobel Prize for achievement in medicine.

5

Adapted from the NIH: http://www.nih.gov/about/NIHoverview.html.

10 Kaposi’s Sarcoma

There is no guarantee that any one Institute will have a guideline on a specific disease, though the National Institutes of Health collectively publish over 600 guidelines for both common and rare diseases. The best way to access NIH guidelines is via the Internet. Although the NIH is organized into many different Institutes and Offices, the following is a list of key Web sites where you are most likely to find NIH clinical guidelines and publications dealing with Kaposi’s sarcoma and associated conditions: ·

Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm

·

National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines available at http://www.nlm.nih.gov/medlineplus/healthtopics.html

·

National Cancer Institute (NCI); guidelines available at http://cancernet.nci.nih.gov/pdq/pdq_treatment.shtml

Among the above, the National Cancer Institute (NCI) is particularly noteworthy. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.6 Specifically, the Institute: ·

Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements.

·

Conducts research in its own laboratories and clinics.

·

Supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships.

·

Supports research projects in cancer control.

·

Supports a national network of cancer centers.

·

Collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities.

·

Encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research.

·

Collects and disseminates information on cancer.

This paragraph has been adapted from the NCI: http://www.nci.nih.gov/. “Adapted” signifies that a passage has been reproduced exactly or slightly edited for this book.

6

Guidelines 11

·

Supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants.

The NCI, established under the National Cancer Act of 1937, is the Federal Government’s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. Information dissemination is made possible through the NCI Online at www.cancer.gov. Cancer.gov offers to the public and physicians up-to-date information on the latest cancer research, current and upcoming clinical trials, statistics, research programs, and research funding. The following patient guideline was recently published by the NCI on Kaposi’s sarcoma.

What Is Kaposi’s Sarcoma?7 Kaposi’s sarcoma (KS) is a disease in which cancer (malignant) cells are found in the tissues under the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or purple patches (lesions) on the skin and/or mucous membranes and spreads to other organs in the body, such as the lungs, liver, or intestinal tract. Until the early 1980’s, Kaposi’s sarcoma was a very rare disease that was found mainly in older men, patients who had organ transplants, or African men. With the Acquired Immunodeficiency Syndrome (AIDS) epidemic in the early 1980’s, doctors began to notice more cases of Kaposi’s sarcoma in Africa and in gay men with AIDS. Kaposi’s sarcoma usually spreads more quickly in these patients. If there are signs of KS, a doctor will examine the skin and lymph nodes carefully (lymph nodes are small bean-shaped structures that are found throughout the body; they produce and store infection-fighting cells). The doctor also may order other tests to see if the patient has other diseases.

The following guidelines appeared on the NCI website on August 16, 2002. The text was last modified in August 2002. The text has been adapted for this sourcebook.

7


The chance of recovery (prognosis) depends on what type of Kaposi’s sarcoma the patient has, the patient’s age and general health, and whether or not the patient has AIDS.

Types of Kaposi’s Sarcoma There is no accepted staging system for Kaposi’s sarcoma. Patients are grouped depending on which type of Kaposi’s sarcoma they have. There are three types of Kaposi’s sarcoma: ·

Classic

·

Immunosuppressive Treatment-Related

·

Epidemic

Classic Classic Kaposi’s sarcoma usually occurs in older men of Jewish, Italian, or Mediterranean heritage. This type of Kaposi’s sarcoma progresses slowly, sometimes over 10 to 15 years. As the disease gets worse, the lower legs may swell and the blood may not be able to flow properly. After some time, the disease may spread to other organs. Many patients with classic Kaposi’s sarcoma may develop another type of cancer later on in their lives.

Immunosuppressive Treatment-Related Kaposi’s sarcoma may occur in people who are taking drugs to make their immune systems weaker (immunosuppressants). The immune system helps the body fight off infection. People who have had an organ transplant (such as a liver or kidney transplant) have to take drugs to prevent their immune system from attacking the new organ.

Epidemic Kaposi’s sarcoma in patients who have Acquired Immunodeficiency Syndrome (AIDS) is called epidemic Kaposi’s sarcoma. AIDS is caused by a virus called the Human Immunodeficiency Virus (HIV), which attacks and weakens the immune system. Infections and other diseases can then invade the body, and the immune system cannot fight against them. Kaposi’s

Guidelines 13

sarcoma in people with AIDS usually spreads more quickly than other kinds of Kaposi’s sarcoma and often is found in many parts of the body.

Recurrent Recurrent disease means that the KS has come back (recurred) after it has been treated. It may come back in the area where it first started or in another part of the body.

How Kaposi’s Sarcoma Is Treated There are treatments for all patients with Kaposi’s sarcoma. Four kinds of treatment are used: ·

Surgery (taking out the cancer)

·

Chemotherapy (using drugs to kill cancer cells)

·

Radiation therapy (using high-dose x-rays to kill cancer cells)

·

Biological therapy (using the body’s immune system to fight cancer)

Radiation Therapy Radiation therapy is a common treatment of Kaposi’s sarcoma. Radiation therapy uses high-dose x-rays or other high-energy rays to kill cancer cells and shrink tumors. Radiation for Kaposi’s sarcoma comes from a machine outside the body (external beam radiation therapy).

Surgery Surgery means taking out the cancer. A doctor may remove the cancer using one of the following: ·

Local excision cuts out the lesion and some of the tissue around it.

·

Electrodesiccation and curettage burns the lesion and removes it with a sharp instrument.

·

Cryotherapy freezes the tumor and kills it.


Chemotherapy Chemotherapy uses drugs to kill cancer cells. Chemotherapy may be taken by pill, or it may be put into the body by a needle in a vein or muscle. Chemotherapy is called a systemic treatment because the drug enters the bloodstream, travels through the body, and can kill cancer cells outside the original site. Chemotherapy for Kaposi’s sarcoma also may be injected into the lesion (intralesional chemotherapy). Biological Therapy Biological therapy tries to get the body to fight the cancer. It uses materials made by the body or made in a laboratory to boost, direct, or restore the body’s natural defenses against disease. Biological therapy is sometimes called biological response modifier (BRM) therapy or immunotherapy.

Treatment by Type Treatment of Kaposi’s sarcoma depends on the type of Kaposi’s sarcoma the patient has, and the patient’s age and general health. Standard treatment may be considered because of its effectiveness in patients in past studies, or participation in a clinical trial may be considered. Not all patients are cured with standard therapy and some standard treatments may have more side effects than are desired. For these reasons, clinical trials are designed to find better ways to treat cancer patients and are based on the most up-to-date information. Clinical trials are ongoing in most parts of the country for most stages of Kaposi’s sarcoma. To learn more about clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-4226237); TTY at 1-800-332-8615.

Classic Kaposi’s Sarcoma Treatment may be one of the following: 1. Radiation therapy. 2. Local excision. 3. Systemic or intralesional chemotherapy. 4. Chemotherapy plus radiation therapy.

Guidelines 15

Immunosuppressive Treatment Related-Kaposi’s Sarcoma Depending on the patient’s condition, the cancer may be controlled if immunosuppressive drugs are stopped. If the patient cannot stop taking these drugs or if this does not work, treatment may be one of the following: 1. Radiation therapy. 2. A clinical trial of chemotherapy.

Epidemic Kaposi’s Sarcoma Treatment may be one of the following: 1. Surgery (local excision, electrodesiccation and curettage, or cryotherapy) with or without radiation therapy. 2. Systemic chemotherapy. Clinical trials are testing new drugs and drug combinations. 3. Biological therapy. 4. A clinical trial evaluating new treatments.

Recurrent Kaposi’s Sarcoma Treatment of recurrent Kaposi’s sarcoma depends on the type of Kaposi’s sarcoma, and the patient’s general health and response to earlier treatments. The patient may want to take part in a clinical trial.

To Learn More Call For more information, U.S. residents may call the National Cancer Institute’s (NCI’s) Cancer Information Service toll-free at 1-800-4-CANCER (1-800-4226237), Monday through Friday from 9:00 a.m. to 4:30 p.m. Deaf and hard-ofhearing callers with TTY equipment may call 1-800-332-8615. The call is free and a trained Cancer Information Specialist is available to answer your questions.


Web Sites and Organizations The NCI’s Cancer.gov Web site (http://cancer.gov) provides online access to information on cancer, clinical trials, and other Web sites and organizations that offer support and resources for cancer patients and their families. There are also many other places where people can get materials and information about cancer treatment and services. Local hospitals may have information on local and regional agencies that offer information about finances, getting to and from treatment, receiving care at home, and dealing with problems associated with cancer treatment.

Publications The NCI has booklets and other materials for patients, health professionals, and the public. These publications discuss types of cancer, methods of cancer treatment, coping with cancer, and clinical trials. Some publications provide information on tests for cancer, cancer causes and prevention, cancer statistics, and NCI research activities. NCI materials on these and other topics may be ordered online or printed directly from the NCI Publications Locator (https://cissecure.nci.nih.gov/ncipubs). These materials can also be ordered by telephone from the Cancer Information Service toll-free at 1-8004-CANCER (1-800-422-6237), TTY at 1-800-332-8615.

LiveHelp The NCI’s LiveHelp service, a program available on several of the Institute’s Web sites, provides Internet users with the ability to chat online with an Information Specialist. The service is available from Monday - Friday 9:00 AM - 10:00 PM Eastern Time. Information Specialists can help Internet users find information on NCI Web sites and answer questions about cancer.

Write For more information from the NCI, please write to this address: National Cancer Institute Office of Communications 31 Center Drive, MSC 2580 Bethesda, MD 20892-2580

Guidelines 17

About PDQ PDQ Is a Comprehensive Cancer Database Available on Cancer.gov PDQ is the National Cancer Institute’s (NCI’s) comprehensive cancer information database. Most of the information contained in PDQ is available online at Cancer.gov (http://cancer.gov), the NCI’s Web site. PDQ is provided as a service of the NCI. The NCI is part of the National Institutes of Health, the federal government’s focal point for biomedical research.

PDQ Contains Cancer Information Summaries The PDQ database contains summaries of the latest published information on cancer prevention, detection, genetics, treatment, supportive care, and complementary and alternative medicine. Most summaries are available in two versions. The health professional versions provide detailed information written in technical language. The patient versions are written in easy-tounderstand, non-technical language. Both versions provide current and accurate cancer information. The PDQ cancer information summaries are developed by cancer experts and reviewed regularly. Editorial Boards made up of experts in oncology and related specialties are responsible for writing and maintaining the cancer information summaries. The summaries are reviewed regularly and changes are made as new information becomes available. The date on each summary (“Date Last Modified”) indicates the time of the most recent change.

PDQ Contains Information on Clinical Trials Before starting treatment, patients may want to think about taking part in a clinical trial. A clinical trial is a study to answer a scientific question, such as whether one treatment is better than another. Trials are based on past studies and what has been learned in the laboratory. Each trial answers certain scientific questions in order to find new and better ways to help cancer patients. During treatment clinical trials, information is collected about new treatments, the risks involved, and how well they do or do not work. If a clinical trial shows that a new treatment is better than one currently being used, the new treatment may become “standard.”


Listings of clinical trials are included in PDQ and are available online at Cancer.gov (http://cancer.gov/clinical_trials). Descriptions of the trials are available in health professional and patient versions. Many cancer doctors who take part in clinical trials are also listed in PDQ. For more information, call the Cancer Information Service: 1-800-4-CANCER (1-800-422-6237); TTY at 1-800-332-8615.

More Guideline Sources The guideline above on Kaposi’s sarcoma is only one example of the kind of material that you can find online and free of charge. The remainder of this chapter will direct you to other sources which either publish or can help you find additional guidelines on topics related to Kaposi’s sarcoma. Many of the guidelines listed below address topics that may be of particular relevance to your specific situation or of special interest to only some patients with Kaposi’s sarcoma. Due to space limitations these sources are listed in a concise manner. Do not hesitate to consult the following sources by either using the Internet hyperlink provided, or, in cases where the contact information is provided, contacting the publisher or author directly.

Topic Pages: MEDLINEplus For patients wishing to go beyond guidelines published by specific Institutes of the NIH, the National Library of Medicine has created a vast and patientoriented healthcare information portal called MEDLINEplus. Within this Internet-based system are “health topic pages.” You can think of a health topic page as a guide to patient guides. To access this system, log on to http://www.nlm.nih.gov/medlineplus/healthtopics.html. Recently, MEDLINEplus listed the following as being relevant to Kaposi’s sarcoma: ·

Guides on Kaposi’s Sarcoma Kaposi's Sarcoma http://www.nlm.nih.gov/medlineplus/kaposissarcoma.html

·

Other Guides Soft Tissue Sarcoma http://www.nlm.nih.gov/medlineplus/softtissuesarcoma.html Lymphoma http://www.nlm.nih.gov/medlineplus/lymphoma.html

Guidelines 19

Hospice Care http://www.nlm.nih.gov/medlineplus/hospicecare.html Cancer http://www.nlm.nih.gov/medlineplus/cancergeneral.html Within the health topic page dedicated to Kaposi’s sarcoma, the following was recently recommended to patients: ·

General/Overviews What Is Kaposi's Sarcoma? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_is_ka posis_sarcoma_21.asp?sitearea=cri

·

Diagnosis/Symptoms Can Kaposi's Sarcoma Be Found Early? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_3x_can_kaposi s_sarcoma_be_found_early_21.asp?sitearea=cri How Is Kaposi's Sarcoma Diagnosed? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_3x_how_is_ka posis_sarcoma_diagnosed_21.asp?sitearea=cri How Is Kaposi's Sarcoma Staged? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_3x_how_is_ka posis_sarcoma_staged_21.asp?sitearea=cri

·

Treatment AIDS-Related KS Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_4x_aidsrelated_ks_21.asp?sitearea=cri Kaposi's Sarcoma (PDQ): Treatment Source: National Cancer Institute http://www.cancer.gov/cancer_information/doc_pdq.aspx?version= patient&viewid=77b099c4-233d-48aa-93bb-6b9ae57ea845


Panretin Consumer Information Source: Food and Drug Administration http://www.fda.gov/cder/consumerinfo/druginfo/panretin.htm Taxanes in Cancer Treatment Source: National Cancer Institute http://cis.nci.nih.gov/fact/7_15.htm ·

Specific Conditions/Aspects What Should You Ask Your Doctor About Kaposi's Sarcoma? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_5x_what_shou ld_you_ask_your_physician_about_kaposis_sarcoma_21.asp?sitearea =cri

·

Organizations American Cancer Society http://www.cancer.org/ National Cancer Institute http://www.cancer.gov/

·

Prevention/Screening Can Kaposi's Sarcoma Be Prevented? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_2x_can_kaposi s_sarcoma_be_prevented_21.asp?sitearea=cri What Are the Risk Factors for Kaposi's Sarcoma? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_2x_what_are_t he_risk_factors_for_kaposis_sarcoma_21.asp?sitearea=&level=

·

Research Thalidomide Shows Activity Against AIDS-Related Kaposi's Sarcoma Source: National Cancer Institute http://www.cancer.gov/clinical_trials/doc.aspx?viewid=95E5EACC -C827-4626-9EF0-D32B5C9F4201

Guidelines 21

What's New in Kaposi's Sarcoma Research and Treatment? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_6x_whats_new _in_kaposis_sarcoma_research_and_treatment_21.asp?sitearea=cri ·

Statistics SEER Cancer Statistics Review 1973-1999: Kaposi's Sarcoma Source: img src='/medlineplus/images/linkpdf.gif' width='100' height='17' border=0 alt='Links to PDF File'> (National Cancer Institute http://seer.cancer.gov/csr/1973_1999/kaposi.pdf What Are the Key Statistics for Kaposi's Sarcoma? Source: American Cancer Society http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_t he_key_statistics_for_kaposis_sarcoma_21.asp?sitearea=cri

If you do not find topics of interest when browsing health topic pages, then you can choose to use the advanced search utility of MEDLINEplus at http://www.nlm.nih.gov/medlineplus/advancedsearch.html. This utility is similar to the NIH Search Utility, with the exception that it only includes material linked within the MEDLINEplus system (mostly patient-oriented information). It also has the disadvantage of generating unstructured results. We recommend, therefore, that you use this method only if you have a very targeted search.

The Combined Health Information Database (CHID) CHID Online is a reference tool that maintains a database directory of thousands of journal articles and patient education guidelines on Kaposi’s sarcoma and related conditions. One of the advantages of CHID over other sources is that it offers summaries that describe the guidelines available, including contact information and pricing. CHID’s general Web site is http://chid.nih.gov/. To search this database, go to http://chid.nih.gov/detail/detail.html. In particular, you can use the advanced search options to look up pamphlets, reports, brochures, and information kits. The following was recently posted in this archive: ·

Info Plus: Maladie de Kaposi ou Sarcome de Kaposi.. [Info Plus: Kaposi's Sarcoma.] Contact: AIDES Federation Nationale, 247 Rue de Belleville, Paris.


Summary: This pamphlet explains the symptoms, stages, treatment options, and recent research on Kaposis's sarcoma, a skin cancer which frequently accompanies the later stages of AIDS. Early symptoms consist of small skin lesions, often around the feet, ankles, arms, chest, face, and mouth. If the body's immune system is adequate, these lesions remain localized and respond to treatment. However, with many AIDS patients the lesions multiply, grow, swell, and even enter internal organs such as the digestive tract and the lungs. Treatment possibilities include the topical application or injection of alpha interferon, radiation therapy, laser treatment, surgery, and cryotherapy. In advanced cases where the immune system is depressed, chemotherapy may be appropriate. Recent research has also experimented with acne medication (retinoids) and the stimulation of the immune system.

The National Guideline Clearinghouse™ The National Guideline Clearinghouse™ offers hundreds of evidence-based clinical practice guidelines published in the United States and other countries. You can search their site located at http://www.guideline.gov by using the keyword “Kaposi’s sarcoma” or synonyms. Healthfinder™ Healthfinder™ is an additional source sponsored by the U.S. Department of Health and Human Services which offers links to hundreds of other sites that contain healthcare information. This Web site is located at http://www.healthfinder.gov. Again, keyword searches can be used to find guidelines. The following was recently found in this database: ·

Kaposi's Sarcoma (PDQ®): Treatment Summary: Current information on the prevention, detection, treatment, and supportive care of Kaposi's Sarcoma from NCI's PDQ® database. The information is reviewed and updated each month by oncology experts. Source: National Cancer Institute, National Institutes of Health http://www.healthfinder.gov/scripts/recordpass.asp?RecordType=0&R ecordID=1883

Guidelines 23

The NIH Search Utility After browsing the references listed at the beginning of this chapter, you may want to explore the NIH Search Utility. This allows you to search for documents on over 100 selected Web sites that comprise the NIH-WEBSPACE. Each of these servers is “crawled” and indexed on an ongoing basis. Your search will produce a list of various documents, all of which will relate in some way to Kaposi’s sarcoma. The drawbacks of this approach are that the information is not organized by theme and that the references are often a mix of information for professionals and patients. Nevertheless, a large number of the listed Web sites provide useful background information. We can only recommend this route, therefore, for relatively rare or specific disorders, or when using highly targeted searches. To use the NIH search utility, visit the following Web page: http://search.nih.gov/index.html.

Additional Web Sources A number of Web sites that often link to government sites are available to the public. These can also point you in the direction of essential information. The following is a representative sample: ·

AOL: http://search.aol.com/cat.adp?id=168&layer=&from=subcats

·

drkoop.comÒ: http://www.drkoop.com/conditions/ency/index.html

·

Family Village: http://www.familyvillage.wisc.edu/specific.htm

·

Google: http://directory.google.com/Top/Health/Conditions_and_Diseases/

·

Med Help International: http://www.medhelp.org/HealthTopics/A.html

·

Open Directory Project: http://dmoz.org/Health/Conditions_and_Diseases/

·

Yahoo.com: http://dir.yahoo.com/Health/Diseases_and_Conditions/

·

WebMDÒHealth: http://my.webmd.com/health_topics

Vocabulary Builder The material in this chapter may have contained a number of unfamiliar words. The following Vocabulary Builder introduces you to terms used in this chapter that have not been covered in the previous chapter: Cryotherapy: Any method that uses cold temperature to treat disease. [NIH]


Curettage: Removal of tissue with a curette, a spoon-shaped instrument with a sharp edge. [NIH] Electrodesiccation: The drying of tissue by a high-frequency electric current applied with a needle-shaped electrode. [NIH] Epidemic: Occurring suddenly in numbers clearly in excess of normal expectancy; said especially of infectious diseases but applied also to any disease, injury, or other health-related event occurring in such outbreaks. [EU] Immunodeficiency: The decreased ability of the body to fight infection and disease. [NIH] Immunosuppressive: responses. [NIH]

Describes the ability to lower immune system

Immunotherapy: Treatment to stimulate or restore the ability of the immune system to fight infection and disease. Also used to lessen side effects that may be caused by some cancer treatments. Also called biological therapy or biological response modifier (BRM) therapy. [NIH] Interferon: A biological response modifier (a substance that can improve the body's natural response to disease). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. These substances are normally produced by the body. They are also made in the laboratory for use in treating cancer and other diseases. [NIH] Lesion: An area of abnormal tissue change. [NIH] Liver: A large, glandular organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile. [NIH] Lymph: The almost colorless fluid that travels through the lymphatic system and carries cells that help fight infection and disease. [NIH] Retinoid: Vitamin A or a vitamin A-like compound. [NIH] Sarcoma: A cancer of the bone, cartilage, fat, muscle, blood vessels or other connective or supportive tissue. [NIH] Staging: Performing exams and tests to learn the extent of the cancer within the body, especially whether the disease has spread from the original site to other parts of the body. [NIH] Systemic: Affecting the entire body. [NIH] Topical: On the surface of the body. [NIH] Virus: Submicroscopic organism that causes infectious disease. In cancer therapy, some viruses may be made into vaccines that help the body build an immune response to, and kill, tumor cells. [NIH]

Seeking Guidance 25

CHAPTER 2. SEEKING GUIDANCE Overview Some patients are comforted by the knowledge that a number of organizations dedicate their resources to helping people with Kaposi’s sarcoma. These associations can become invaluable sources of information and advice. Many associations offer aftercare support, financial assistance, and other important services. Furthermore, healthcare research has shown that support groups often help people to better cope with their conditions.8 In addition to support groups, your physician can be a valuable source of guidance and support. Therefore, finding a physician that can work with your unique situation is a very important aspect of your care. In this chapter, we direct you to resources that can help you find patient organizations and medical specialists. We begin by describing how to find associations and peer groups that can help you better understand and cope with Kaposi’s sarcoma. The chapter ends with a discussion on how to find a doctor that is right for you.

Associations and Kaposi’s Sarcoma As mentioned by the Agency for Healthcare Research and Quality, sometimes the emotional side of an illness can be as taxing as the physical side.9 You may have fears or feel overwhelmed by your situation. Everyone has different ways of dealing with disease or physical injury. Your attitude, your expectations, and how well you cope with your condition can all Churches, synagogues, and other houses of worship might also have groups that can offer you the social support you need. 9 This section has been adapted from http://www.ahcpr.gov/consumer/diaginf5.htm. 8


influence your well-being. This is true for both minor conditions and serious illnesses. For example, a study on female breast cancer survivors revealed that women who participated in support groups lived longer and experienced better quality of life when compared with women who did not participate. In the support group, women learned coping skills and had the opportunity to share their feelings with other women in the same situation.

Finding More Associations There are a number of directories that list additional medical associations that you may find useful. While not all of these directories will provide different information than what is listed above, by consulting all of them, you will have nearly exhausted all sources for patient associations. The National Cancer Institute (NCI) The National Cancer Institute (NCI) has complied a list of national organizations that offer services to people with cancer and their families. To view the list, see the NCI fact sheet online at the following Web address: http://cis.nci.nih.gov/fact/8_1.htm. The name of each organization is accompanied by its contact information and a brief explanation of its services. The National Health Information Center (NHIC) The National Health Information Center (NHIC) offers a free referral service to help people find organizations that provide information about Kaposi’s sarcoma. For more information, see the NHIC’s Web site at http://www.health.gov/NHIC/ or contact an information specialist by calling 1-800-336-4797.

DIRLINE A comprehensive source of information on associations is the DIRLINE database maintained by the National Library of Medicine. The database comprises some 10,000 records of organizations, research centers, and government institutes and associations which primarily focus on health and biomedicine. DIRLINE is available via the Internet at the following Web site: http://dirline.nlm.nih.gov/. Simply type in “Kaposi’s sarcoma” (or a

Seeking Guidance 27

synonym) or the name of a topic, and the site will list information contained in the database on all relevant organizations.

The Combined Health Information Database Another comprehensive source of information on healthcare associations is the Combined Health Information Database. Using the “Detailed Search” option, you will need to limit your search to “Organizations” and “Kaposi’s sarcoma”. Type the following hyperlink into your Web browser: http://chid.nih.gov/detail/detail.html. To find associations, use the drop boxes at the bottom of the search page where “You may refine your search by.” For publication date, select “All Years.” Then, select your preferred language and the format option “Organization Resource Sheet.” By making these selections and typing in “Kaposi’s sarcoma” (or synonyms) into the “For these words:” box, you will only receive results on organizations dealing with Kaposi’s sarcoma. You should check back periodically with this database since it is updated every 3 months. The National Organization for Rare Disorders, Inc. The National Organization for Rare Disorders, Inc. has prepared a Web site that provides, at no charge, lists of associations organized by specific diseases. You can access this database at the following Web site: http://www.rarediseases.org/search/orgsearch.html. Select the option called “Organizational Database (ODB)” and type “Kaposi’s sarcoma” (or a synonym) in the search box.

Cancer Support Groups10 People diagnosed with cancer and their families face many challenges that may leave them feeling overwhelmed, afraid, and alone. It can be difficult to cope with these challenges or to talk to even the most supportive family members and friends. Often, support groups can help people affected by cancer feel less alone and can improve their ability to deal with the uncertainties and challenges that cancer brings. Support groups give people who are affected by similar diseases an opportunity to meet and discuss ways to cope with the illness.

10

This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/8_8.htm.


How Can Support Groups Help? People who have been diagnosed with cancer sometimes find they need assistance coping with the emotional as well as the practical aspects of their disease. In fact, attention to the emotional burden of cancer is sometimes part of a patient’s treatment plan. Cancer support groups are designed to provide a confidential atmosphere where cancer patients or cancer survivors can discuss the challenges that accompany the illness with others who may have experienced the same challenges. For example, people gather to discuss the emotional needs created by cancer, to exchange information about their disease—including practical problems such as managing side effects or returning to work after treatment—and to share their feelings. Support groups have helped thousands of people cope with these and similar situations. Can Family Members and Friends Participate in Support Groups? Family and friends are affected when cancer touches someone they love, and they may need help in dealing with stresses such as family disruptions, financial worries, and changing roles within relationships. To help meet these needs, some support groups are designed just for family members of people diagnosed with cancer; other groups encourage families and friends to participate along with the cancer patient or cancer survivor. How Can People Find Support Groups? Many organizations offer support groups for people diagnosed with cancer and their family members or friends. The NCI fact sheet National Organizations That Offer Services to People with Cancer and Their Families lists many cancer-concerned organizations that can provide information about support groups. This fact sheet is available on the Internet at http://cis.nci.nih.gov/fact/8_1.htm, or it can be ordered from the Cancer Information Service at 1–800–4–CANCER (1–800–422–6237). Some of these organizations provide information on their Web sites about contacting support groups. Doctors, nurses, or hospital social workers who work with cancer patients may also have information about support groups, such as their location, size, type, and how often they meet. Most hospitals have social services departments that provide information about cancer support programs.

Seeking Guidance 29

Additionally, many newspapers carry a special health supplement containing information about where to find support groups.

What Types of Support Groups Are Available? Several kinds of support groups are available to meet the individual needs of people at all stages of cancer treatment, from diagnosis through follow-up care. Some groups are general cancer support groups, while more specialized groups may be for teens or young adults, for family members, or for people affected by a particular disease. Support groups may be led by a professional, such as a psychiatrist, psychologist, or social worker, or by cancer patients or survivors. In addition, support groups can vary in approach, size, and how often they meet. Many groups are free, but some require a fee (people can contact their health insurance company to find out whether their plan will cover the cost). It is important for people to find an atmosphere that is comfortable and meets their individual needs. Online Support Groups In addition to support groups, commercial Internet service providers offer forums and chat rooms for people with different illnesses and conditions. WebMDÒ, for example, offers such a service at their Web site: http://boards.webmd.com/roundtable. These online self-help communities can help you connect with a network of people whose concerns are similar to yours. Online support groups are places where people can talk informally. If you read about a novel approach, consult with your doctor or other healthcare providers, as the treatments or discoveries you hear about may not be scientifically proven to be safe and effective.

The Cancer Information Service11 The Cancer Information Service (CIS) is a program of the National Cancer Institute (NCI), the Nation’s lead agency for cancer research. As a resource for information and education about cancer, the CIS is a leader in helping people become active participants in their own health care by providing the latest information on cancer in understandable language. Through its network of regional offices, the CIS serves the United States, Puerto Rico, the U.S. Virgin Islands, and the Pacific Islands. 11

This section has been adapted from the NCI: http://cis.nci.nih.gov/fact/2_5.htm.


For 25 years, the Cancer Information Service has provided the latest and most accurate cancer information to patients and families, the public, and health professionals by: ·

Interacting with people one-on-one through its Information Service,

·

Working with organizations through its Partnership Program,

·

Participating in research efforts to find the best ways to help people adopt healthier behaviors,

·

Providing access to NCI information over the Internet. How Does the CIS Assist the Public?

Through the CIS toll-free telephone service (1–800–4–CANCER), callers speak with knowledgeable, caring staff who are experienced at explaining medical information in easy-to-understand terms. CIS information specialists answer calls in English and Spanish. They also provide cancer information to deaf and hard of hearing callers through the toll-free TTY number (1–800– 332–8615). CIS staff has access to comprehensive, accurate information from the NCI on a range of cancer topics, including the most recent advances in cancer treatment. They take as much time as each caller needs, provide thorough and personalized attention, and keep all calls confidential. The CIS also provides live, online assistance to users of NCI Web sites through LiveHelp, an instant messaging service that is available from 9:00 a.m. to 7:30 p.m. Eastern time, Monday through Friday. Through LiveHelp, information specialists provide answers to questions about cancer and help in navigating Cancer.gov, the NCI’s Web site. Through the telephone numbers or LiveHelp service, CIS users receive: ·

Answers to their questions about cancer, including ways to prevent cancer, symptoms and risks, diagnosis, current treatments, and research studies;

·

Written materials from the NCI;

·

Referrals to clinical trials and cancer-related services, such as treatment centers, mammography facilities, or other cancer organizations;

·

Assistance in quitting smoking from information specialists trained in smoking cessation counseling.

Seeking Guidance 31

What Kind of Assistance Does the CIS Partnership Program Offer? Through its Partnership Program, the CIS collaborates with established national, state, and regional organizations to reach minority and medically underserved audiences with cancer information. Partnership Program staff provide assistance to organizations developing programs that focus on breast and cervical cancer, clinical trials, tobacco control, and cancer awareness for special populations. To reach those in need, the CIS: ·

Helps bring cancer information to people who do not traditionally seek health information or who may have difficulties doing so because of educational, financial, cultural, or language barriers;

·

Provides expertise to organizations to help strengthen their ability to inform people they serve about cancer; and

·

Links organizations with similar goals and helps them plan and evaluate programs, develop coalitions, conduct training on cancer-related topics, and use NCI resources. How Do CIS Research Efforts Assist the Public?

The CIS plays an important role in research by studying the most effective ways to communicate with people about healthy lifestyles; health risks; and options for preventing, diagnosing, and treating cancer. The ability to conduct health communications research is a unique aspect of the CIS. Results from these research studies can be applied to improving the way the CIS communicates about cancer and can help other programs communicate more effectively. How Do People Reach the Cancer Information Service? ·

To speak with a CIS information specialist call 1–800–4–CANCER (1–800– 422–6237), 9:00 a.m. to 4:30 p.m. local time, Monday through Friday. Deaf or hard of hearing callers with TTY equipment may call 1–800–332–8615.

·

To obtain online assistance visit the NCI’s Cancer Information Web site at http://cancer.gov/cancer_information and click on the LiveHelp link between 9:00 a.m. and 7:30 p.m. Eastern time, Monday through Friday.

·

For information 24 hours a day, 7 days a week call 1–800–4–CANCER and select option 4 to hear recorded information at any time.

·

Visit NCI’s Web site at http://cancer.gov on the Internet.

·

Visit the CIS Web site at http://cancer.gov/cis on the Internet.


Finding Cancer Resources in Your Community12 If you have cancer or are undergoing cancer treatment, there are places in your community to turn to for help. There are many local organizations throughout the country that offer a variety of practical and support services to people with cancer. However, people often don’t know about these services or are unable to find them. National cancer organizations can assist you in finding these resources, and there are a number of things you can do for yourself. Whether you are looking for a support group, counseling, advice, financial assistance, transportation to and from treatment, or information about cancer, most neighborhood organizations, local health care providers, or area hospitals are a good place to start. Often, the hardest part of looking for help is knowing the right questions to ask. What Kind of Help Can I Get? Until now, you probably never thought about the many issues and difficulties that arise with a diagnosis of cancer. There are support services to help you deal with almost any type of problem that might occur. The first step in finding the help you need is knowing what types of services are available. The following pages describe some of these services and how to find them. ·

Information on Cancer. Most national cancer organizations provide a range of information services, including materials on different types of cancer, treatments, and treatment-related issues.

·

Counseling. While some people are reluctant to seek counseling, studies show that having someone to talk to reduces stress and helps people both mentally and physically. Counseling can also provide emotional support to cancer patients and help them better understand their illness. Different types of counseling include individual, group, family, self-help (sometimes called peer counseling), bereavement, patient-to-patient, and sexuality.

·

Medical Treatment Decisions. Often, people with cancer need to make complicated medical decisions. Many organizations provide hospital and physician referrals for second opinions and information on clinical trials (research studies with people), which may expand treatment options.

12

Adapted from the NCI: http://cis.nci.nih.gov/fact/8_9.htm.

Seeking Guidance 33

·

Prevention and Early Detection. While cancer prevention may never be 100 percent effective, many things (such as quitting smoking and eating healthy foods) can greatly reduce a person’s risk for developing cancer. Prevention services usually focus on smoking cessation and nutrition. Early detection services, which are designed to detect cancer when a person has no symptoms of disease, can include referrals for screening mammograms, Pap tests, or prostate exams.

·

Home Health Care. Home health care assists patients who no longer need to stay in a hospital or nursing home, but still require professional medical help. Skilled nursing care, physical therapy, social work services, and nutrition counseling are all available at home.

·

Hospice Care. Hospice is care focused on the special needs of terminally ill cancer patients. Sometimes called palliative care, it centers around providing comfort, controlling physical symptoms, and giving emotional support to patients who can no longer benefit from curative treatment. Hospice programs provide services in various settings, including the patient’s home, hospice centers, hospitals, or skilled nursing facilities. Your doctor or social worker can provide a referral for these services.

·

Rehabilitation. Rehabilitation services help people adjust to the effects of cancer and its treatment. Physical rehabilitation focuses on recovery from the physical effects of surgery or the side effects associated with chemotherapy. Occupational or vocational therapy helps people readjust to everyday routines, get back to work, or find employment.

·

Advocacy. Advocacy is a general term that refers to promoting or protecting the rights and interests of a certain group, such as cancer patients. Advocacy groups may offer services to assist with legal, ethical, medical, employment, legislative, or insurance issues, among others. For instance, if you feel your insurance company has not handled your claim fairly, you may want to advocate for a review of its decision.

·

Financial. Having cancer can be a tremendous financial burden to cancer patients and their families. There are programs sponsored by the government and nonprofit organizations to help cancer patients with problems related to medical billing, insurance coverage, and reimbursement issues. There are also sources for financial assistance, and ways to get help collecting entitlements from Medicaid, Medicare, and the Social Security Administration.

·

Housing/Lodging. Some organizations provide lodging for the family of a patient undergoing treatment, especially if it is a child who is ill and the parents are required to accompany the child to treatment.


·

Children’s Services. A number of organizations provide services for children with cancer, including summer camps, make-a-wish programs, and help for parents seeking child care. How to Find These Services

Often, the services that people with cancer are looking for are right in their own neighborhood or city. The following is a list of places where you can begin your search for help. ·

The hospital, clinic, or medical center where you see your doctor, received your diagnosis, or where you undergo treatment should be able to give you information. Your doctor or nurse may be able to tell you about your specific medical condition, pain management, rehabilitation services, home nursing, or hospice care.

·

Most hospitals also have a social work, home care, or discharge planning department. This department may be able to help you find a support group, a nonprofit agency that helps people who have cancer, or the government agencies that oversee Social Security, Medicare, and Medicaid. While you are undergoing treatment, be sure to ask the hospital about transportation, practical assistance, or even temporary child care. Talk to a hospital financial counselor in the business office about developing a monthly payment plan if you need help with hospital expenses.

·

The public library is an excellent source of information, as are patient libraries at many cancer centers. A librarian can help you find books and articles through a literature search.

·

A local church, synagogue, YMCA or YWCA, or fraternal order may provide financial assistance, or may have volunteers who can help with transportation and home care. Catholic Charities, the United Way, or the American Red Cross may also operate local offices. Some of these organizations may provide home care, and the United Way’s information and referral service can refer you to an agency that provides financial help. To find the United Way serving your community, visit their online directory at http://www.unitedway.org on the Internet or look in the White Pages of your local telephone book.

·

Local or county government agencies may offer low-cost transportation (sometimes called para-transit) to individuals unable to use public transportation. Most states also have an Area Agency on Aging that offers low-cost services to people over 60. Your hospital or community social worker can direct you to government agencies for entitlements,

Seeking Guidance 35

including Social Security, state disability, Medicaid, income maintenance, and food stamps. (Keep in mind that most applications to entitlement programs take some time to process.) The Federal government also runs the Hill-Burton program (1–800–638–0742), which funds certain medical facilities and hospitals to provide cancer patients with free or low-cost care if they are in financial need. Getting the Most from a Service: What to Ask No matter what type of help you are looking for, the only way to find resources to fit your needs is to ask the right questions. When you are calling an organization for information, it is important to think about what questions you are going to ask before you call. Many people find it helpful to write out their questions in advance, and to take notes during the call. Another good tip is to ask the name of the person with whom you are speaking in case you have follow-up questions. Below are some of the questions you may want to consider if you are calling or visiting a new agency and want to learn about how they can help: ·

How do I apply [for this service]?

·

Are there eligibility requirements? What are they?

·

Is there an application process? How long will it take? What information will I need to complete the application process? Will I need anything else to get the service?

·

Do you have any other suggestions or ideas about where I can find help?

The most important thing to remember is that you will rarely receive help unless you ask for it. In fact, asking can be the hardest part of getting help. Don’t be afraid or ashamed to ask for assistance. Cancer is a very difficult disease, but there are people and services that can ease your burdens and help you focus on your treatment and recovery.

Finding Doctors Who Specialize in Cancer Care13 One of the most important aspects of your treatment will be the relationship between you and your doctor or specialist. All patients with Kaposi’s sarcoma must go through the process of selecting a physician. A common way to find a doctor who specializes in cancer care is to ask for a referral 13

Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm.


from your primary care physician. Sometimes, you may know a specialist yourself, or through the experience of a family member, coworker, or friend. The following resources may also be able to provide you with names of doctors who specialize in treating specific diseases or conditions. However, these resources may not have information about the quality of care that the doctors provide. ·

Your local hospital or its patient referral service may be able to provide you with a list of specialists who practice at that hospital.

·

Your nearest National Cancer Institute (NCI)-designated cancer center can provide information about doctors who practice at that center. The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information, including Web sites, for NCIdesignated cancer treatment centers around the country. Many of the cancer centers’ Web sites have searchable directories of physicians who practice at each facility. The NCI’s fact sheet is available at http://cis.nci.nih.gov/fact/1_2.htm on the Internet, or by calling the Cancer Information Service (CIS) at 1–800–4–CANCER (1–800–422–6237).

·

The American Board of Medical Specialties (ABMS) publishes a list of board-certified physicians. The Official ABMS Directory of Board Certified Medical Specialists lists doctors’ names along with their specialty and their educational background. This resource is available in most public libraries. The ABMS also has a Web site that can be used to verify whether a specific physician is board-certified. This free service is located at http://www.abms.org/newsearch.asp on the Internet. Verification of a physician’s board certification can also be obtained by calling the ABMS at 1–866–275–2267 (1–866–ASK–ABMS).

·

The American Medical Association (AMA) provides an online service called AMA Physician Select that offers basic professional information on virtually every licensed physician in the United States and its possessions. The database can be searched by doctor’s name or by medical specialty. The AMA Physician Select service is located at http://www.ama-assn.org/aps/amahg.htm on the Internet.

·

The American Society of Clinical Oncologists (ASCO) provides an online list of doctors who are members of ASCO. The member database has the names and affiliations of over 15,000 oncologists worldwide. It can be searched by doctor’s name, institution’s name, location, and/or type of board certification. This service is available at the following Web address: http://www.asco.org/people/db/html/m_db.htm on the Internet.

Seeking Guidance 37

·

The American College of Surgeons (ACOS) Fellowship Database is an online list of surgeons who are Fellows of the ACOS. The list can be searched by doctor’s name, geographic location, or medical specialty. This service is located at http://web.facs.org/acsdir/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.

·

Local medical societies may maintain lists of doctors in each specialty.

·

Public and medical libraries may have print directories of doctors’ names, listed geographically by specialty.

·

Your local Yellow Pages may have doctors listed by specialty under “Physicians.” The Agency for Healthcare Research and Quality

The Agency for Healthcare Research and Quality (AHRQ) offers Your Guide to Choosing Quality Health Care, which has information for consumers on choosing a health plan, a doctor, a hospital, or a long-term care provider. The Guide includes suggestions and checklists that you can use to determine which doctor or hospital is best for you. This resource is available at http://www.ahrq.gov/consumer/qntool.htm on the Internet. You can also order the Guide by calling the AHRQ Publications Clearinghouse at 1–800– 358–9295. If you are a member of a health insurance plan, your choice may be limited to doctors who participate in your plan. Your insurance company can provide you with a list of participating primary care doctors and specialists. It is important to ask your insurance company if the doctor you choose is accepting new patients through your health plan. You also have the option of seeing a doctor outside your health plan and paying the costs yourself. If you have a choice of health insurance plans, you may first wish to consider which doctor or doctors you would like to use, then choose a plan that includes your chosen physician(s).

The National Comprehensive Cancer Network The National Comprehensive Cancer Network (NCCN) Physician Directory lists specialists who practice in the NCCN’s 19 member institutions across the U.S. To access the directory, go to http://www.nccn.org/ and click on “Physician Directory“. To use this service, you will be required to scroll to the bottom of the page and select “I agree.” Enter your search criteria and


select “Find” at the bottom of the page. To obtain more information on a physician or institution, contact the institution’s Physician Referral Department or the NCCN Patient Information and Referral Service at 1-888909-NCCN or [email protected]. If the previous sources did not meet your needs, you may want to log on to the Web site of the National Organization for Rare Disorders (NORD) at http://www.rarediseases.org/. NORD maintains a database of doctors with expertise in various rare diseases. The Metabolic Information Network (MIN), 800-945-2188, also maintains a database of physicians with expertise in various metabolic diseases.

Selecting Your Doctor14 There are many factors to consider when choosing a doctor. To make the most informed decision, you may wish to speak with several doctors before choosing one. When you meet with each doctor, you might want to consider the following: ·

Does the doctor have the education and training to meet my needs?

·

Does the doctor use the hospital that I have chosen?

·

Does the doctor listen to me and treat me with respect?

·

Does the doctor explain things clearly and encourage me to ask questions?

·

What are the doctor’s office hours?

·

Who covers for the doctor when he or she is unavailable? Will that person have access to my medical records?

·

How long does it take to get an appointment with the doctor?

If you are choosing a surgeon, you may wish to ask additional questions about the surgeon’s background and experience with specific procedures. These questions may include: ·

Is the surgeon board-certified?15

·

Has the surgeon been evaluated by a national professional association of surgeons, such as the American College of Surgeons (ACOS)?

14 This

section has been adapted from the AHRQ: http://www.ahrq.gov/consumer/qntascii/qntdr.htm 15 While board certification is a good measure of a doctor’s knowledge, it is possible to receive quality care from doctors who are not board certified.

Seeking Guidance 39

·

At which treatment facility or facilities does the surgeon practice?

·

How often does the surgeon perform the type of surgery I need?

·

How many of these procedures has the surgeon performed? What was the success rate?

It is important for you to feel comfortable with the specialist that you choose, because you will be working closely with that person to make decisions about your cancer treatment. Trust your own observations and feelings when deciding on a doctor for your medical care. Other health professionals and support services may also be important during cancer treatment. The National Cancer Institute fact sheet Your Health Care Team: Your Doctor Is Only the Beginning has information about these providers and services, and how to locate them. This fact sheet is located at http://cis.nci.nih.gov/fact/8_10.htm on the Internet, or can be obtained by calling the CIS at 1–800–4–CANCER (1–800–422–6237).

Working with Your Doctor16 Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care and have better results. Here are some tips to help you and your doctor become partners: ·

You know important things about your symptoms and your health history. Tell your doctor what you think he or she needs to know.

·

It is important to tell your doctor personal information, even if it makes you feel embarrassed or uncomfortable.

·

Bring a “health history” list with you (and keep it up to date).

·

Always bring any medications you are currently taking with you to the appointment, or you can bring a list of your medications including dosage and frequency information. Talk about any allergies or reactions you have had to your medications.

·

Tell your doctor about any natural or alternative medicines you are taking.

·

Bring other medical information, such as x-ray films, test results, and medical records.

This section has been adapted from the AHRQ: www.ahrq.gov/consumer/qntascii/qntdr.htm.

16


·

Ask questions. If you don’t, your doctor will assume that you understood everything that was said.

·

Write down your questions before your visit. List the most important ones first to make sure that they are addressed.

·

Consider bringing a friend with you to the appointment to help you ask questions. This person can also help you understand and/or remember the answers.

·

Ask your doctor to draw pictures if you think that this would help you understand.

·

Take notes. Some doctors do not mind if you bring a tape recorder to help you remember things, but always ask first.

·

Let your doctor know if you need more time. If there is not time that day, perhaps you can speak to a nurse or physician assistant on staff or schedule a telephone appointment.

·

Take information home. Ask for written instructions. Your doctor may also have brochures and audio and videotapes that can help you.

·

After leaving the doctor’s office, take responsibility for your care. If you have questions, call. If your symptoms get worse or if you have problems with your medication, call. If you had tests and do not hear from your doctor, call for your test results. If your doctor recommended that you have certain tests, schedule an appointment to get them done. If your doctor said you should see an additional specialist, make an appointment.

By following these steps, you will enhance the relationship you will have with your physician.

Finding a Cancer Treatment Facility17 Choosing a treatment facility is another important consideration for getting the best medical care possible. Although you may not be able to choose which hospital treats you in an emergency, you can choose a facility for scheduled and ongoing care. If you have already found a doctor for your cancer treatment, you may need to choose a facility based on where your doctor practices. Your doctor may be able to recommend a facility that

Adapted from the NCI: http://cis.nci.nih.gov/fact/7_47.htm. At this Web site, information on how to find treatment facilities is also available for patients living outside the U.S.

17

Seeking Guidance 41

provides quality care to meet your needs. You may wish to ask the following questions when considering a treatment facility: ·

Has the facility had experience and success in treating my condition?

·

Has the facility been rated by state, consumer, or other groups for its quality of care?

·

How does the facility check and work to improve its quality of care?

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Has the facility been approved by a nationally recognized accrediting body, such as the American College of Surgeons (ACOS) and/or the Joint Commission on Accredited Healthcare Organizations (JCAHO)?

·

Does the facility explain patients’ rights and responsibilities? Are copies of this information available to patients?

·

Does the treatment facility offer support services, such as social workers and resources to help me find financial assistance if I need it?

·

Is the facility conveniently located?

If you are a member of a health insurance plan, your choice of treatment facilities may be limited to those that participate in your plan. Your insurance company can provide you with a list of approved facilities. Although the costs of cancer treatment can be very high, you have the option of paying out-of-pocket if you want to use a treatment facility that is not covered by your insurance plan. If you are considering paying for treatment yourself, you may wish to discuss the potential costs with your doctor beforehand. You may also want to speak with the person who does the billing for the treatment facility. In some instances, nurses and social workers can provide you with more information about coverage, eligibility, and insurance issues. The following resources may help you find a hospital or treatment facility for your care: ·

The NCI fact sheet The National Cancer Institute Cancer Centers Program describes and gives contact information for NCI-designated cancer treatment centers around the country.

·

The ACOS accredits cancer programs at hospitals and other treatment facilities. More than 1,400 programs in the United States have been designated by the ACOS as Approved Cancer Programs. The ACOS Web site offers a searchable database of these programs at http://web.facs.org/cpm/default.htm on the Internet. The ACOS can be contacted at 633 North Saint Clair Street, Chicago, IL 60611–3211; or by telephone at 312–202–5000.


·

The JCAHO is an independent, not-for-profit organization that evaluates and accredits health care organizations and programs in the United States. It also offers information for the general public about choosing a treatment facility. The JCAHO Web site is located at http://www.jcaho.org on the Internet. The JCAHO is located at One Renaissance Boulevard, Oakbrook Terrace, IL 60181–4294. The telephone number is 630–792–5800.

·

The JCAHO offers an online Quality Check service that patients can use to determine whether a specific facility has been accredited by the JCAHO and view the organization’s performance reports. This service is located at http://www.jcaho.org/qualitycheck/directry/directry.asp on the Internet.

·

The AHRQ publication Your Guide To Choosing Quality Health Care has suggestions and checklists for choosing the treatment facility that is right for you.

Additional Cancer Support Information In addition to the references above, the NCI has set up guidance Web sites that offers information on issues relating to cancer. These include: ·

Facing Forward - A Guide for Cancer Survivors: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=cc93a 843-6fc0-409e-8798-5c65afc172fe

·

Taking Time: Support for People With Cancer and the People Who Care About Them: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=21a4 6445-a5c8-4fee-95a3-d9d0d665077a

·

When Cancer Recurs: Meeting the Challenge: http://www.cancer.gov/cancer_information/doc_img.aspx?viewid=9e13 d0d2-b7de-4bd6-87da-5750300a0dab

·

Your Health Care Team: Your Doctor Is Only the Beginning: http://cis.nci.nih.gov/fact/8_10.htm

Vocabulary Builder The following vocabulary builder provides definitions of words used in this chapter that have not been defined in previous chapters:

Seeking Guidance 43

Bereavement: Refers to the whole process of grieving and mourning and is associated with a deep sense of loss and sadness. [NIH] Erythema: A name applied to redness of the skin produced by congestion of the capillaries, which may result from a variety of causes, the etiology or a specific type of lesion often being indicated by a modifying term. [EU] Inflammation: A response of redness, swelling, pain, and a feeling of heat in certain areas which is meant to protect tissues affected by injury or disease. [NIH]

Palliative: 1. Affording relief, but not cure. 2. An alleviating medicine. [EU] Photosensitivity: An abnormal cutaneous response involving the interaction between photosensitizing substances and sunlight or filtered or artificial light at wavelengths of 280-400 mm. There are two main types : photoallergy and photoxicity. [EU] Screening: Checking for disease when there are no symptoms. [NIH]

Clinical Trials 45

CHAPTER 3. CLINICAL TRIALS AND KAPOSI’S SARCOMA Overview Very few medical conditions have a single treatment. The basic treatment guidelines that your physician has discussed with you, or those that you have found using the techniques discussed in Chapter 1, may provide you with all that you will require. For some patients, current treatments can be enhanced with new or innovative techniques currently under investigation. In this chapter, we will describe how clinical trials work and show you how to keep informed of trials concerning Kaposi’s sarcoma.

What Is a Clinical Trial?18 Clinical trials involve the participation of people in medical research. Most medical research begins with studies in test tubes and on animals. Treatments that show promise in these early studies may then be tried with people. The only sure way to find out whether a new treatment is safe, effective, and better than other treatments for Kaposi’s sarcoma is to try it on patients in a clinical trial.

The discussion in this chapter has been adapted from the NIH and the NEI: www.nei.nih.gov/netrials/ctivr.htm.

18


What Kinds of Clinical Trials Are There? Clinical trials are carried out in three phases: ·

Phase I. Researchers first conduct Phase I trials with small numbers of patients and healthy volunteers. If the new treatment is a medication, researchers also try to determine how much of it can be given safely.

·

Phase II. Researchers conduct Phase II trials in small numbers of patients to find out the effect of a new treatment on Kaposi’s sarcoma.

·

Phase III. Finally, researchers conduct Phase III trials to find out how new treatments for Kaposi’s sarcoma compare with standard treatments already being used. Phase III trials also help to determine if new treatments have any side effects. These trials--which may involve hundreds, perhaps thousands, of people--can also compare new treatments with no treatment. How Is a Clinical Trial Conducted?

Various organizations support clinical trials at medical centers, hospitals, universities, and doctors’ offices across the United States. The “principal investigator” is the researcher in charge of the study at each facility participating in the clinical trial. Most clinical trial researchers are medical doctors, academic researchers, and specialists. The “clinic coordinator” knows all about how the study works and makes all the arrangements for your visits. All doctors and researchers who take part in the study on Kaposi’s sarcoma carefully follow a detailed treatment plan called a protocol. This plan fully explains how the doctors will treat you in the study. The “protocol” ensures that all patients are treated in the same way, no matter where they receive care. Clinical trials are controlled. This means that researchers compare the effects of the new treatment with those of the standard treatment. In some cases, when no standard treatment exists, the new treatment is compared with no treatment. Patients who receive the new treatment are in the treatment group. Patients who receive a standard treatment or no treatment are in the “control” group. In some clinical trials, patients in the treatment group get a new medication while those in the control group get a placebo. A placebo is a harmless substance, a “dummy” pill, that has no effect on Kaposi’s sarcoma. In other clinical trials, where a new surgery or device (not a medicine) is being tested, patients in the control group may receive a “sham

Clinical Trials 47

treatment.” This treatment, like a placebo, has no effect on Kaposi’s sarcoma and does not harm patients. Researchers assign patients “randomly” to the treatment or control group. This is like flipping a coin to decide which patients are in each group. If you choose to participate in a clinical trial, you will not know which group you will be appointed to. The chance of any patient getting the new treatment is about 50 percent. You cannot request to receive the new treatment instead of the placebo or sham treatment. Often, you will not know until the study is over whether you have been in the treatment group or the control group. This is called a “masked” study. In some trials, neither doctors nor patients know who is getting which treatment. This is called a “double masked” study. These types of trials help to ensure that the perceptions of the patients or doctors will not affect the study results. Natural History Studies Unlike clinical trials in which patient volunteers may receive new treatments, natural history studies provide important information to researchers on how Kaposi’s sarcoma develops over time. A natural history study follows patient volunteers to see how factors such as age, sex, race, or family history might make some people more or less at risk for Kaposi’s sarcoma. A natural history study may also tell researchers if diet, lifestyle, or occupation affects how a disease or disorder develops and progresses. Results from these studies provide information that helps answer questions such as: How fast will a disease or disorder usually progress? How bad will the condition become? Will treatment be needed? What Is Expected of Patients in a Clinical Trial? Not everyone can take part in a clinical trial for a specific disease or disorder. Each study enrolls patients with certain features or eligibility criteria. These criteria may include the type and stage of disease or disorder, as well as, the age and previous treatment history of the patient. You or your doctor can contact the sponsoring organization to find out more about specific clinical trials and their eligibility criteria. If you are interested in joining a clinical trial, your doctor must contact one of the trial’s investigators and provide details about your diagnosis and medical history. If you participate in a clinical trial, you may be required to have a number of medical tests. You may also need to take medications and/or undergo


surgery. Depending upon the treatment and the examination procedure, you may be required to receive inpatient hospital care. Or, you may have to return to the medical facility for follow-up examinations. These exams help find out how well the treatment is working. Follow-up studies can take months or years. However, the success of the clinical trial often depends on learning what happens to patients over a long period of time. Only patients who continue to return for follow-up examinations can provide this important long-term information.

Recent Trials on Kaposi’s Sarcoma The National Institutes of Health and other organizations sponsor trials on various diseases and disorders. Because funding for research goes to the medical areas that show promising research opportunities, it is not possible for the NIH or others to sponsor clinical trials for every disease and disorder at all times. The following lists recent trials dedicated to Kaposi’s sarcoma.19 If the trial listed by the NIH is still recruiting, you may be eligible. If it is no longer recruiting or has been completed, then you can contact the sponsors to learn more about the study and, if published, the results. Further information on the trial is available at the Web site indicated. Please note that some trials may no longer be recruiting patients or are otherwise closed. Before contacting sponsors of a clinical trial, consult with your physician who can help you determine if you might benefit from participation. ·

A Phase II Study of Interleukin-12 with either Liposomal Doxorubicin or 96 Hour Continuous Infusion Paclitaxel in AIDS-Associated Kaposi's Sarcoma Followed by Chronic Administration of Interleukin12 Condition(s): HIV Infection; Kaposi's Sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: This study will test the safety and effectiveness of combined therapy using liposomal doxorubicin (Doxil) and interleukin12 (IL-12) for treating Kaposi's sarcoma (KS ) in people infected with HIV. Doxil is approved to treat KS, but its use in combination with IL-12 is experimental. IL-12 is a substance produced by cells that helps the immune system fight certain viruses-perhaps including KSHV, the virus that causes KS-and also inhibits new blood vessel formation, which is associated with KS. IL-12 production is decreased in people infected with

19

These are listed at www.ClinicalTrials.gov.

Clinical Trials 49

HIV. This study will test whether replacing IL-12 will help the body fight KS and produce better treatment results than Doxil alone. HIV-positive patients 13 years of age or older with Kaposi's sarcoma may be eligible for this study. Candidates will have a medical history, physical examination, blood and urine tests, electrocardiogram, chest X-ray and biopsy of a KS lesion (removal of a small piece of tumor tissue, under local anesthetic, for microscopic examination), and possibly other tests. Patients with a history of heart disease may also have a MUGA test (nuclear medicine test of the heart). Participants will receive Doxil infusions intravenously (through a vein) for up to 6 doses once every 3 weeks. They will also receive IL-12 twice a week, injected under the skin. IL-12 injections will continue for up to 3 years, as long as the drug shows benefit and is well tolerated. (Patients will be taught to give themselves the injections.) Pictures of the patient's entire body-focusing on the KS lesions- will be taken when they enter the study, then every 3 weeks while taking Doxil and IL-12, and then once every 8 weeks while receiving IL-12 alone. Participants will be evaluated in the clinic once a week for the first 6 weeks of therapy, then every 3 weeks until the last dose of Doxil, and monthly thereafter. They will be asked about side effects of treatment and may have a physical examination. KS lesions will also be measured. A chest X-ray and blood tests to measure CD4 cells and HIV viral load will be done every 9 weeks while on Doxil with IL-12 and then every 8 weeks while on IL-12 alone. KS lesions will be biopsied before starting drug treatment, at week 9 of treatment, and when the lesions have responded sufficiently for the disease to be considered in partial remission. Patients may be asked to undergo additional skin biopsies for research purposes. Also at the beginning of the study, at week 12 and at week 24, patients will undergo three noninvasive procedures to determine blood vessel density and blood flow in skin areas affected by KS. They are Doppler imaging, which uses a low power laser beam to measure blood flow through the vessels; multi-spectral imaging, which uses a light instrument that can estimate total blood volume and oxygen content; and infrared thermal imaging, which uses a special camera to produce a picture of the temperature of KS lesions in order to assess blood flow. If medically indicated, patients may undergo additional procedures such as computed tomography (CT) or magnetic resonance imaging (MRI) scans. The first 10 patients enrolled in the study will also be asked to have intensive blood sampling once every 2 to 6 hours for 24 hours in order to determine blood levels of IL-12 of and other substances affected by IL-12. A small catheter will be placed in an arm vein to draw the samples in order to avoid repeated needle sticks. Phase(s): Phase II


Study Type: Interventional Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Clinical Studies Support Center/NCI 1-888-624-1937 [email protected] Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00008879;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Antiviral Therapy in Treating Patients With Slowly Progressing HIVRelated Kaposi's Sarcoma Condition(s): epidemic Kaposi's sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): Centro di Riferimento Oncologico - Aviano Purpose - Excerpt: RATIONALE: HIV virus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Antiviral therapy acts against the HIV virus and may be an effective treatment for Kaposi's sarcoma. PURPOSE: Phase II trial to study the effectiveness of antiviral therapy in treating patients with slowly progressing HIV-related Kaposi's sarcoma. Phase(s): Phase II Study Type: Treatment Contact(s): Italy; Centro di Riferimento Oncologico - Aviano, Aviano, 33081, Italy; Recruiting; Umberto Tirelli 0434-659284. Study chairs or principal investigators: Umberto Tirelli, Study Chair; Centro di Riferimento Oncologico - Aviano Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003419;jsessionid=F543639 98A2C504DD1392249BA66C15F

·

Assessment of Blood Vessel Density in Kaposi's Sarcoma Lesions Condition(s): Kaposi's Sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: The purpose of this study is to develop imaging techniques to determine the density of blood vessels and the amount of blood flow in Kaposi's sarcoma (KS) tumors. KS tumors depend on the formation of new blood vessels for their growth. Some experimental therapies for KS are directed at reducing the amount of blood vessels and

Clinical Trials 51

blood flow in these lesions. Measurement of blood vessel density and blood flow in these lesions could be useful in evaluating the effectiveness of both standard and experimental treatments for this disease. Patients 18 years of age or older with Kaposi's sarcoma involving the skin may be eligible for this study. Participants will have photographs taken of their lesions and will undergo three imaging procedures (described below) at the beginning of the study (baseline) and then about once every 3 months or so while on the study (up to 2 years) to compare the test results over time. (Imaging may be done at more or less frequent intervals depending on the findings.) A small amount of blood (less than a tablespoon) will be drawn the day of each imaging procedure. Laser Doppler imaging - This technique measures the amount of blood flow in KS lesions by scanning the lesions with a low-power laser beam. Each lesion takes about 3 minutes to scan. The imaging may be done before and after a blood pressure cuff around the arm is inflated for a short time (usually less than 30 seconds). Multi-spectral imaging - This technique uses light to measure the total blood volume in each lesion and how much oxygen is in the blood. Oxygen is carried to the body's cells by a protein in red blood cells called hemoglobin. The light on the multi-spectral imaging instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to it or not. It takes about 2 minutes to scan each lesion. Infrared thermal imaging - This test uses a special camera to take digital infrared pictures of the skin. Images formed of the temperature of the KS lesions are used to assess blood flow in the lesions. This imaging takes about 1 minute per lesion. Study Type: Observational Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Clinical Studies Support Center/NCI 1-888-624-1937 [email protected] Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00026793;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma Condition(s): epidemic Kaposi's sarcoma; recurrent Kaposi's sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute Malignancies Clinical Trials Consortium

(NCI);

AIDS

Associated

Purpose - Excerpt: RATIONALE: Drugs such as BMS-275291 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.


PURPOSE: Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have HIV -related Kaposi's sarcoma. Phase(s): Phase I; Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00024024;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers Condition(s): Acquired Immunodeficiency Syndrome; Kaposi's Sarcoma; Leukemia; Lymphoma; Tumor Virus Infection; HIV Infections Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: This protocol presents the rationale, 25-year historical review, and methods for multidisciplinary, low-risk studies of individuals referred to the NCI Viral Epidemiology Branch (VEB). Referrals are generally for unusual types of cancer or related conditions, known, or suspected to be related to viruses. Kaposi's sarcoma in two homosexual men evaluated in 1981 is a classic example. These referral cases provide the basis for pilot studies that generate hypotheses, the development of protocols for formal investigations of promising leads, and help to set priorities for VEB. A VEB investigator who is a Staff Member at the NIH Clinical Center, interviews each subject, performs a physical examination, draws a blood sample, and, when appropriate for the disease or virus under study, obtains other clinically indicated biological specimens, such as urine, sputum, saliva, tears, semen, Pap smear, or cervical, anal, oral, or nasal swabs. On occasion, other relatively non-invasive studies may be indicated. Skin testing with conventional, licensed antigens for assessment of cellular immunity may be performed, and skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated for other reasons. Otherwise no surgery is performed, and no therapy is administered. Clinical referral to other components of NCI, NIH, or the private sector are made as needed. The biological specimens are frozen or otherwise preserved to be batch tested in current assays or future assays that will be developed. Such laboratory testing is performed either at VEB's own support laboratory, or collaboratively in other NCI, NIH, or extramural laboratories that have the needed expertise for the disease or

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virus under study. Occasionally, repeated or more long-term evaluation is required. More often, a single evaluation in the NIH outpatient clinic, or either at a collaborating physician's office or other suitable site in the field, is sufficient. The VEB investigator provides counseling relevant to the virus or disease under study, and about the interim study results. He or she makes appropriate referral if needed (e.g., to the Genetic Epidemiology Branch for genetic counseling). Clinically relevant results and the VEB investigator's interpretation of these results, are provided in writing to the subject's primary caregiver. Confidentially of the information that is obtained is carefully protected. The results of the study are summarized for publication in the peer review literature. Study Type: Observational Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Patient Recruitment and Public Liaison Office 1-800-411-1222 [email protected]; TTY 1-866-411-1010 Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001560;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

COL-3 in Treating Patients With HIV-Related Kaposi's Sarcoma Condition(s): epidemic Kaposi's sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute Malignancies Clinical Trials Consortium

(NCI);

AIDS

Associated

Purpose - Excerpt: RATIONALE: COL-3 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV -related Kaposi's sarcoma. Phase(s): Phase II Study Type: Treatment Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00020683;jsessionid=F543639 98A2C504DD1392249BA66C15F


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Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors Condition(s): lung cancer; pancreatic cancer; gastric cancer; salivary gland cancer; lip and oral cavity cancer; adult soft tissue sarcoma; esophageal cancer; head and neck cancer; bone cancer; ovarian sarcoma; melanoma; ovarian epithelial cancer; bladder cancer; prostate cancer; Kaposi's sarcoma; oropharyngeal cancer; breast cancer; uterine sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Norris Cotton Cancer Center Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors. Phase(s): Phase I Study Type: Treatment Contact(s): New Hampshire; Norris Cotton Cancer Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting; James R. Rigas 603-650-6344. Study chairs or principal investigators: Konstantin H. Dragnev, Study Chair; Norris Cotton Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00014456;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma Condition(s): HIV Seropositivity; Kaposi's Sarcoma; HIV Infections Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: This study will examine the effects of potent anti-HIV therapy on factors thought to be involved in causing Kaposi's sarcoma (KS) in patients with HIV infection or KS. These include certain blood proteins and a virus called Kaposi's sarcoma-associated herpes virus, or KSHV. (This virus is also called human herpes virus-8, or HHV-8). Patients in this study will receive standard treatment; experimental therapy is not used. HIV-infected patients 13 years of age and older with KS or whose blood tests positive for KSHV may be eligible for this study.

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Candidates will be screened with a history, physical examination and blood tests for HIV and KSHV. Participants will receive up to 2 years of a combination of anti-HIV drugs while on the study. (Patients who are already taking antiviral therapy when they join the study will have their medications stopped for 4 weeks, during which blood tests will be done to measure the effects of stopping treatment on KSHV and other factors. Therapy will then be restarted.) During the study period, blood and saliva samples will be tested for any changes in immune function directed at KSHV and blood proteins that may be linked with KS. Patients who have KS lesions will have their lesions biopsied for microscopic examination of possible immune-related changes. (A biopsy is removal of a small tissue sample under local anesthetic.) Patients with KS lesions will also be evaluated for clinical response to treatment. Study Type: Observational Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Clinical Studies Support Center/NCI 1-888-624-1937 [email protected] Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00006171;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Genetic Factors and Interrelationships for Sexual Orientation, Susceptibility to HIV and Kaposi's Sarcoma, Alcoholism and Psychological Traits, and Histocompatibility Antigens Condition(s): Alcoholism; HIV Infection; Homosexuality; Kaposi's Sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors


interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function. Study Type: Observational Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; PRPL 8004111222 [email protected] Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001294;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Mitoxantrone in Treating Patients With Sarcoma of the Abdomen Condition(s): recurrent Kaposi's sarcoma; gastrointestinal stromal tumor; adult fibrosarcoma; recurrent adult soft tissue sarcoma; adult rhabdomyosarcoma; adult leiomyosarcoma; recurrent tumors of the Ewing's family Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Memorial Sloan-Kettering Cancer Center Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of mitoxantrone in treating patients who have recurrent sarcoma of the abdomen. Phase(s): Phase I Study Type: Treatment Contact(s): New York; Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting; Murray F. Brennan 210-617-5300, ext. 4448. Study chairs or principal investigators: Murray F. Brennan, Study Chair; Memorial Sloan-Kettering Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003756;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Paclitaxel Compared With Doxorubicin in Treating Patients With Advanced AIDS-Related Kaposi's Sarcoma Condition(s): epidemic Kaposi's sarcoma Study Status: This study is currently recruiting patients.

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Sponsor(s): National Cancer Institute (NCI); AIDS Associated Malignancies Clinical Trials Consortium; Southwest Oncology Group; Eastern Cooperative Oncology Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel is more effective than doxorubicin in treating patients with advanced AIDS -related Kaposi's sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with that of doxorubicin in treating patients who have advanced AIDS-related Kaposi's sarcoma. Phase(s): Phase III Study Type: Treatment Contact(s): Alabama; AIDS Associated Malignancies Clinical Trials Consortium, Birmingham, Alabama, 35233, United States; Recruiting; Jamie Hayden Von Roenn 312-695-6180. Study chairs or principal investigators: Robert L. Comis, Study Chair; Eastern Cooperative Oncology Group; Jamie Hayden Von Roenn, Study Chair; Charles A. Coltman, Jr., Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003350;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma Condition(s): epidemic Kaposi's sarcoma; recurrent Kaposi's sarcoma Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); AIDS Associated Malignancies Clinical Trials Consortium; Eastern Cooperative Oncology Group Purpose - Excerpt: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS -related Kaposi's sarcoma. Phase(s): Phase II Study Type: Treatment Contact(s): Alabama; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting; Jeanette Y. Lee 205-934-5165. Study chairs or principal investigators: Robert L. Comis, Study Chair; Eastern Cooperative Oncology Group; Jamie Hayden Von Roenn, Study Chair


Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00003008;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin Condition(s): lip and oral cavity cancer; skin cancer; head and neck cancer; lymphoma; Kaposi's sarcoma; oropharyngeal cancer; breast cancer Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI); Ireland Cancer Center Purpose - Excerpt: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer or cancer that is metastatic to the skin. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin. Phase(s): Phase I Study Type: Treatment Contact(s): Ohio; Ireland Cancer Center, Cleveland, Ohio, 44106-5065, United States; Recruiting; Scot C. Remick 216-844-1196. Study chairs or principal investigators: Scot C. Remick, Study Chair; Ireland Cancer Center Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00023790;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States Condition(s): Kaposi's Sarcoma; Herpesviridae Infection Study Status: This study is currently recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United States and its potential impact on the U.S. population. KSHV is a newly discovered virus that is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a primary mode of transmission. Reports of non-sexual transmission in parts of Africa and

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the Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually. This study will: Compare the prevalence of KSHV among different demographic groups in the United States - Examine the association between KSHV and high risk behaviors such as drug use (marijuana and cocaine), sexual behavior (age at first sexual intercourse and number of sexual partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis C) Estimate the prevalence of KSHV in the United States. Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a program of periodic surveys conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics. The survey is designed to provide national estimates of health status for the United States non-institutionalized civilian population by means of household interviews, standardized physical examinations, and blood sample collection and testing. NHANES III-the seventh in a series of national examination studies-was conducted from 1988 to 1994. This study will use the HANES data to identify risks associated with a KSHVpositive blood test in the survey population. The study plans to include all 19,754 participants (67% of the 29,314 participants originally examined) for whom blood samples were collected and remain available. Study Type: Observational Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States; Recruiting; Patient Recruitment and Public Liaison Office 1-800-411-1222 [email protected]; TTY 1-866-411-1010 Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00026728;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Sequus Pharmaceuticals Purpose - Excerpt: To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDSrelated Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.


Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002318;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): University of California San Francisco Purpose - Excerpt: To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy. Phase(s): Phase I Study Type: Interventional Contact(s): California; San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, 941102859, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002262;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDSRelated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Otsuka America Pharmaceuticals Purpose - Excerpt: To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma. Phase(s): Phase II Study Type: Interventional

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Contact(s): California; UCLA School of Medicine, Los Angeles, California, 900121973, United States; Illinois; Northwestern Univ Med School, Chicago, Illinois, 60611, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002131;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS Condition(s): Acquired Immunodeficiency Syndrome; Kaposi's Sarcoma; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): National Cancer Institute (NCI) Purpose - Excerpt: Biological Response Modifier Therapy. Interleukin-12, IL-12, NSC-672423. Complete evaluation of KS lesions, including whole body counts and assessments will be performed every 4 weeks. Photographs and radiological studies will be performed every 8 weeks. Phase(s): Phase I Study Type: Interventional Contact(s): Maryland; National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland, 20892, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001508;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Study of ALRT 1057 Topical Gel in Patients with AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Anderson Clinical Research; Ligand Pharmaceuticals Purpose - Excerpt: The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin. Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002439;jsessionid=F543639 98A2C504DD1392249BA66C15F


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A Study of ALRT1057 in Patients with AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Anderson Clinical Research; Ligand Pharmaceuticals Purpose - Excerpt: The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS). Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002188;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Sequus Pharmaceuticals Purpose - Excerpt: To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002319;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Study of Ro 24-7429 in Patients with HIV-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections

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Study Status: This study is no longer recruiting patients. Sponsor(s): Hoffmann-La Roche Ltd Purpose - Excerpt: To study the effects of Ro 24-7429 on tumor growth in patients with HIV-related Kaposi's sarcoma. To study the safety and tolerance, effects on HIV replication, and immunologic effects of Ro 247429 in this patient population. To explore relationships between exposure to Ro 24-7429 and its metabolites with its antitumor and antiviral activities and drug toxicity. Phase(s): Phase II Study Type: Interventional Contact(s): California; CARE Ctr / UCLA Med Ctr, Los Angeles, California, 900951793, United States; Massachusetts; New England Deaconess Hosp, Boston, Massachusetts, 02215, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002314;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Study of Targretin Capsules in Patients with AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Ligand Pharmaceuticals Purpose - Excerpt: The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS). Phase(s): Phase II Study Type: Interventional Contact(s): California; Desert Univ School of Medicine, Palm Springs, California, 92262, United States; Louisiana; Tulane Univ School of Medicine, New Orleans, Louisiana, 70112, United States; Pennsylvania; Milton S Hershey Med Ctr, Hershey, Pennsylvania, 17033, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002212;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals Condition(s): Sarcoma, Kaposi; HIV Infections


Study Status: This study is no longer recruiting patients. Sponsor(s): Baker Norton Pharmaceuticals Purpose - Excerpt: To determine response rate, median time to tumor progression, qualitative and quantitative toxicity and reversibility of toxicity in patients with advanced refractory AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour infusion of paclitaxel every 14 days. To evaluate the clinical benefit of paclitaxel in this patient population by evaluating self-reported responses to the Symptom Distress Scale and by documenting and evaluating any changes in their lymphedema, pain and disfiguring facial lesions. Phase(s): Phase II Study Type: Interventional Contact(s): Massachusetts; Massachusetts Gen Hosp / AIDS Oncology Research, Boston, Massachusetts, 02114, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002189;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID); Bristol-Myers Squibb Purpose - Excerpt: To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy. Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000807;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Lederle Laboratories Purpose - Excerpt: To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma. Phase(s): Phase II Study Type: Interventional Contact(s): New York; Saint Luke's - Roosevelt Hosp Ctr, New York, New York, 10019, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002259;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary. Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Clinical Solutions Purpose - Excerpt: To determine the objective tumor response and remission rate of AIDS-related Kaposi's sarcomas (KS) following a single dose of tin ethyl etiopurpurin (SnET2) followed by photodynamic therapy (PDT). To determine the systemic and local toxicity, and morbidity safety profile of SnET2-PDT. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002167;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients.


Sponsor(s): Sequus Pharmaceuticals Purpose - Excerpt: To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS. Phase(s): Phase III Study Type: Interventional Contact(s): Massachusetts; Beth Israel Hosp, Boston, Massachusetts, 02215, United States; New York; Mount Sinai Med Ctr, New York, New York, 10029, United States; Texas; Twelve Oaks Hosp, Houston, Texas, 77074, United States; Washington; Virginia Mason Research Center / Clinical Trial Unit, Seattle, Washington, 98101, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002105;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Cytran Purpose - Excerpt: The purpose of this study is to see if it is safe and effective to use IM862 to treat Kaposi's sarcoma (KS) in AIDS patients. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002445;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): SUGEN

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Purpose - Excerpt: The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors. Study Type: Interventional Contact(s): California; UCLA Care Ctr / Ctr for Hlth Sciences, Los Angeles, California, 900951793, United States; Norris Cancer Ctr / USC, Los Angeles, California, 90033, United States; Saint Francis Mem Hosp / HIV Care Unit, San Francisco, California, 94109, United States; New York; New York Univ Med Ctr, New York, New York, 10016, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002226;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

SU5416 in Patients with AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): SUGEN Purpose - Excerpt: The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS) where chemotherapy has failed. Phase(s): Phase II Study Type: Interventional Contact(s): California; Alison L. Hannah, South San Francisco, California, 94080, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005932;jsessionid=F543639 98A2C504DD1392249BA66C15F

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SU5416 in Patients with AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): SUGEN Purpose - Excerpt: The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS). Phase(s): Phase II Study Type: Interventional


Contact(s): California; Alison L. Hannah, South San Francisco, California, 94080, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00005931;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

The Safety and Effectiveness of Interferon Alfa-2B Plus Didanosine in Patients with Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID); Schering-Plough; Bristol-Myers Squibb Purpose - Excerpt: Primary: To evaluate the safety, toxicity, and antitumor activity of two doses of interferon alfa-2b (IFN-alpha) combined with a fixed dose of didanosine (ddI) in patients with Kaposi's sarcoma associated with HIV infection. Secondary: To evaluate the effects of combined IFN-alpha and ddI treatment on HIV expression and markers of immune function. Previous studies have shown that IFNalpha can induce regression of Kaposi's sarcoma and suppression of HIV in some patients. Although various trials using IFN-alpha in combination with the nucleoside analogue zidovudine have demonstrated a high degree of antitumor activity and evidence of HIV suppression, the overlapping toxicity (primarily neutropenia) of these two agents has proven dose-limiting. The toxicity profile of ddI suggests that this drug may be better tolerated than zidovudine when combined with IFN-alpha. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001114;jsessionid=F543639 98A2C504DD1392249BA66C15F

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The Safety and Effectiveness of Ritonavir in the Treatment of HIVRelated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Abbott Laboratories Purpose - Excerpt: To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.

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Phase(s): Phase II Study Type: Interventional Contact(s): Australia; Saint Vincent's Hosp Med Centre, Sydney, Australia; Prince Henry's Hosp / Med Oncology, Sydney, Australia Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002366;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Topical Use of 4,4'-Dihydroxybenzophenone-2,4Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders Condition(s): Sarcoma, Kaposi; HIV Infections; Lymphoproliferative Disorders Study Status: This study is no longer recruiting patients. Sponsor(s): DEKK-TEC Purpose - Excerpt: To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders. Phase(s): Phase I Study Type: Interventional Contact(s): Louisiana; DEKK - TEC Inc, New Orleans, Louisiana, 70119, United States Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00002153;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma. Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is no longer recruiting patients. Sponsor(s): Sequus Pharmaceuticals Purpose - Excerpt: To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who


have previously received systemic chemotherapy with or without an anthracycline. Phase(s): Phase III Study Type: Interventional Contact(s): California; Sequus California, 94025, United States

Pharmaceutical

Inc,

Menlo

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A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated dose of each drug in combination and to define doses to be used in Phase II trials. AZT has been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in combination with IFN-A or IFN-A2A is warranted. Phase(s): Phase I Study Type: Interventional Contact(s): Florida; Univ of Miami School of Medicine, Miami, Florida, 331361013, United States. Study chairs or principal investigators: Fischl MA, Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000725;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To determine the safety as well as the most effective dose of sargramostim (GM-CSF; granulocyte-macrophage colony stimulating factor) that will prevent the side effects caused by the combined use of zidovudine (AZT) and various doses of cancer-fighting drugs (doxorubicin, bleomycin, and vincristine) in AIDS patients with Kaposi's sarcoma (KS). Patients included in this study have KS, which is a type of cancer that occurs in nearly 20 percent of patients with AIDS. AIDS patients with extensive KS require treatment with effective cytotoxic (anti-cancer) agents to reduce the tumor size and with antiretroviral agents such as AZT to prevent or ameliorate the development of opportunistic infections. Due to the significant toxic effect of both cytotoxic and antiviral agents on the bone marrow where new blood cells are generated, the combination of these agents is expected to result in complications such as granulocytopenia (very low granulocyte counts). Hematopoietic growth factors such as GM-CSF may reduce the severity and duration of marrow suppression. This may improve survival. Clinical trials of GM-CSF in HIV infected individuals with or without granulocytopenia have shown that the progenitor cells (early blood cells) are responsive to GM-CSF. Phase(s): Phase I Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000681;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related


Kaposi's sarcoma. To assess pharmacokinetics and tumor response of the drug. Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease. Phase(s): Phase I Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000763;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients with AIDS-associated Kaposi's sarcoma ( KS ), to learn about the side effects of these drugs when they are given together for 8 weeks, and to find out whether the combination of GM-CSF, IFN-A2b, and AZT has any effect on KS, HIV, or the immune system. Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients. AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections. Test tube experiments show that when IFNA2b and AZT are used together, they reduce the growth of the HIV virus much more effectively than when either drug is used alone. In recent studies of the combination of interferon alpha and AZT in patients with KS, more than 40 percent of the patients showed shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil) which is important in the body's defense against infection. Recombinant human GM-CSF is a

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human protein which is produced in bacteria. It has been shown to cause an increase in the WBC count. Phase(s): Phase I Study Type: Interventional Contact(s): New York; Mem Sloan - Kettering Cancer Ctr, New York, New York, 10021, United States. Study chairs or principal investigators: SE Krown, Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000694;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To determine the safety and tolerance of interleukin-4 (IL-4) in patients with AIDS-related Kaposi's sarcoma. To determine the effects of IL-4 on tumor growth in patients with AIDS-related Kaposi's sarcoma. IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposi's sarcoma cells in vitro. Phase(s): Phase I Study Type: Interventional Contact(s): California; UCLA CARE Ctr, Los Angeles, California, 90095, United States; Massachusetts; Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, 02114, United States; Beth Israel Deaconess - West Campus, Boston, Massachusetts, 02215, United States. Study chairs or principal investigators: Miles S, Study Chair; Scadden D, Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000769;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma Condition(s): HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID)


Purpose - Excerpt: To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDSassociated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan. Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions. Phase(s): Phase III Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000994;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics of AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is reasonable to assume that a synergism and an enhanced antitumor response may be seen with combination therapy. A study to evaluate the safety and effectiveness of AZT in the combination with IFN-A2A is warranted. Phase(s): Phase I Study Type: Interventional Contact(s): New York; Mem Sloan - Kettering Cancer Ctr, New York, New York, 10021, United States. Study chairs or principal investigators: Krown S, Study Chair

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A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients with AIDS Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is administered to patients with advanced Kaposi's sarcoma together with one of two different doses of zidovudine (AZT). The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned. Phase(s): Phase I Study Type: Interventional Contact(s): California; UCLA CARE Ctr, Los Angeles, California, 90095, United States; Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States; USC School of Medicine / Norris Cancer Hosp, Los Angeles, California, 90033, United States. Study chairs or principal investigators: PS Gill, Study Chair; S Miles, Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000987;jsessionid=F543639 98A2C504DD1392249BA66C15F

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A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDSRelated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): Novum; National Institute of Allergy and Infectious Diseases (NIAID); Bristol-Myers Squibb Purpose - Excerpt: To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine


(dideoxycytidine; ddC). AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections. Phase(s): Phase I Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000954;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin. Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000996;jsessionid=F543639 98A2C504DD1392249BA66C15F

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Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID); Sequus Pharmaceuticals; Amgen

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Purpose - Excerpt: To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00001059;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of


toxicity, treatment failures, and disease recurrences resulting from drugresistant virus mutants. Phase(s): Phase I Study Type: Interventional Contact(s): California; UCLA CARE Ctr, Los Angeles, California, 90095, United States; Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States; USC School of Medicine / Norris Cancer Hosp, Los Angeles, California, 90033, United States; Illinois; Northwestern Univ Med School, Chicago, Illinois, 60611, United States. Study chairs or principal investigators: S Miles, Study Chair Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000695;jsessionid=F543639 98A2C504DD1392249BA66C15F ·

Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID); Bristol-Myers Squibb Purpose - Excerpt: To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for determining the effect of oral VP-16 on Kaposi's sarcoma. VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study. Phase(s): Phase I Study Type: Interventional Contact(s): see Web site below

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Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma Condition(s): Sarcoma, Kaposi; HIV Infections Study Status: This study is completed. Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) Purpose - Excerpt: To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. Phase(s): Phase II Study Type: Interventional Contact(s): see Web site below Web Site: http://clinicaltrials.gov/ct/gui/show/NCT00000687;jsessionid=F543639 98A2C504DD1392249BA66C15F


Benefits and Risks20 What Are the Benefits of Participating in a Clinical Trial? If you are interested in a clinical trial, it is important to realize that your participation can bring many benefits to you and society at large: ·

A new treatment could be more effective than the current treatment for Kaposi’s sarcoma. Although only half of the participants in a clinical trial receive the experimental treatment, if the new treatment is proved to be more effective and safer than the current treatment, then those patients who did not receive the new treatment during the clinical trial may be among the first to benefit from it when the study is over.

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If the treatment is effective, then it may improve health or prevent diseases or disorders.

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Clinical trial patients receive the highest quality of medical care. Experts watch them closely during the study and may continue to follow them after the study is over.

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People who take part in trials contribute to scientific discoveries that may help other people with Kaposi’s sarcoma. In cases where certain diseases or disorders run in families, your participation may lead to better care or prevention for your family members. The Informed Consent

Once you agree to take part in a clinical trial, you will be asked to sign an “informed consent.” This document explains a clinical trial’s risks and benefits, the researcher’s expectations of you, and your rights as a patient.

What Are the Risks? Clinical trials may involve risks as well as benefits. Whether or not a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment. There is also the possibility that it may be harmful. The treatment you receive may cause side effects that are serious enough to require medical attention. This section has been adapted from ClinicalTrials.gov, a service of the National Institutes of Health: http://www.clinicaltrials.gov/ct/gui/c/a1r/info/whatis?JServSessionIdzone_ct=9jmun6f291.

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How Is Patient Safety Protected? Clinical trials can raise fears of the unknown. Understanding the safeguards that protect patients can ease some of these fears. Before a clinical trial begins, researchers must get approval from their hospital’s Institutional Review Board (IRB), an advisory group that makes sure a clinical trial is designed to protect patient safety. During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are experiencing any side effects. All the results are carefully recorded and reviewed. In many cases, experts from the Data and Safety Monitoring Committee carefully monitor each clinical trial and can recommend that a study be stopped at any time. You will only be asked to take part in a clinical trial as a volunteer giving informed consent.

What Are a Patient’s Rights in a Clinical Trial? If you are eligible for a clinical trial, you will be given information to help you decide whether or not you want to participate. As a patient, you have the right to: ·

Information on all known risks and benefits of the treatments in the study.

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Know how the researchers plan to carry out the study, for how long, and where.

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Know what is expected of you.

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Know any costs involved for you or your insurance provider.

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Know before any of your medical or personal information is shared with other researchers involved in the clinical trial.

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Talk openly with doctors and ask any questions.

After you join a clinical trial, you have the right to: ·

Leave the study at any time. Participation is strictly voluntary. However, you should not enroll if you do not plan to complete the study.

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Receive any new information about the new treatment.

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Continue to ask questions and get answers.


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Maintain your privacy. Your name will not appear in any reports based on the study.

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Know whether you participated in the treatment group or the control group (once the study has been completed).

What Questions Should You Ask before Deciding to Join a Clinical Trial? Questions you should ask when thinking about joining a clinical trial include the following: ·

What is the purpose of the clinical trial?

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What are the standard treatments for Kaposi’s sarcoma? Why do researchers think the new treatment may be better? What is likely to happen to me with or without the new treatment?

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What tests and treatments will I need? Will I need surgery? Medication? Hospitalization?

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How long will the treatment last? How often will I have to come back for follow-up exams?

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What are the treatment’s possible benefits to my condition? What are the short- and long-term risks? What are the possible side effects?

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Will the treatment be uncomfortable? Will it make me feel sick? If so, for how long?

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How will my health be monitored?

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Where will I need to go for the clinical trial? How will I get there?

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How much will it cost to be in the study? What costs are covered by the study? How much will my health insurance cover?

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Will I be able to see my own doctor? Who will be in charge of my care?

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Will taking part in the study affect my daily life? Do I have time to participate?

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How do I feel about taking part in a clinical trial? Are there family members or friends who may benefit from my contributions to new medical knowledge?

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Clinical Trials and Insurance Coverage21 As you consider enrolling in a clinical trial, you will face the critical issue of how to cover the costs of care. Even if you have health insurance, your coverage may not include some or all of the patient care costs associated with a clinical trial. This is because some health plans define clinical trials as “experimental” or “investigational” procedures. Because lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. This section answers frequently asked questions about insurance coverage for clinical trial participation and directs you to additional information resources. The material here is mainly concerned with treatment clinical trials, since other types of trials (prevention, screening, etc.) are newer and generally not covered by health insurance at all. However, this guide may become more relevant for prevention and other types of trials as these trials grow more common. If you do not have any health insurance, you may find this section helpful for understanding some of the costs that trials involve.

What Costs Do Trials Involve? There are two types of costs associated with a trial: patient care and research. Patient Care Costs Patient care costs fall into two categories: ·

Usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., which occur whether you are participating in a trial or receiving standard treatment. These costs have usually been covered by a third-party health plan, such as Medicare or private insurance.

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Extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution.

Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b. 21


The sponsor and the participant’s health plan need to resolve coverage of these costs for particular trials. Research Costs Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization, such as NCI or a pharmaceutical company.

Criteria Used by Health Plans to Make Reimbursement Decisions about Trials Health insurance companies and managed care companies decide which health care services they will pay for by developing coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan’s judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational. Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment. Your health plan may define specific criteria that a trial must meet before extending coverage, such as the following:

Sponsorship Some plans may only cover costs of trials sponsored by organizations whose review and oversight of the trial is careful and scientifically rigorous, according to standards set by the health plan.

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Trial Phase and Type Some plans may cover patient care costs only for the clinical trials they judge to be “medically necessary” on a case-by-case basis. Trial phase may also affect coverage; for example, while a plan may be willing to cover costs associated with Phase III trials, which include treatments that have already been successful with a certain number of people, the plan may require some documentation of effectiveness before covering a Phase I or II trial. While health plans are interested in efforts to improve prevention and screening, they currently seem less likely to have a review process in place for these trials. Therefore, it may be more difficult to get coverage for the care costs associated with them. Some plans, especially smaller ones, will not cover any costs associated with a clinical trial. Policies vary widely, but in most cases your best bet is to have your doctor initiate discussions with the health plan. Cost “Neutrality” Some health plans may limit coverage to trials they consider cost-neutral (i.e., not significantly more expensive than the treatments considered standard). Lack of Standard Therapy Some plans limit coverage of trials to situations in which no standard therapy is available. Facility and Personnel Qualifications A health plan may require that the facility and medical staff meet specific qualifications to conduct a trial involving unique services, especially intensive therapy such as a bone marrow transplant (high-dose chemotherapy with bone marrow/ stem cell rescue).


Clinical Trials and Medicare Coverage For up-to-date information about Medicare coverage of clinical trials, go to the Web site for the Centers for Medicaid & Medicare (http://www.hcfa.gov/coverage/8d.htm; formerly the Health Care Financing Administration). As of January 2001, the following information was accurate22: What Will Medicare Pay? ·

Anything normally covered is still covered when it is part of a clinical trial. This includes test, procedures, and doctor visits that are ordinarily covered.

·

Anything normally covered even if it is a service or item associated with the experimental treatment. For example, Medicare will pay for the intravenous administration of a new chemotherapy drug being tested in a trial, including any therapy to prevent side effects from the new drug.

·

Anything normally covered even if it resulted from your being in the clinical trial. For example, a test or hospitalization resulting from a side effect of the new treatment that Medicare would ordinarily cover. What Costs Are Not Covered?

·

Investigational items or services being tested in a trial. Sponsors of clinical trials often provide the new drug free, but make sure you ask your doctor before you begin.

·

Items or services used solely for the data collection needs of the trial.

·

Anything being provided free by the sponsor of the trial. What Kinds of Clinical Trials Are Covered?

NCI’s Cancer Information Service has provided a fact sheet for Medicare beneficiaries at the following Web site: http://cis.nci.nih.gov/fact/8_14.htm. In general, cancer treatment and diagnosis trials are covered if: On June 7, 2000, Present Clinton announced that Medicare would revise its payment policy to reimburse the routine patient care costs of clinical trials. The announcement is available for public viewing at the following Web address: http://www.cancer.gov/clinical_trials/doc.aspx?viewid=320DD013-BA7A-4177-A0002011089F34A0. 22

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·

They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other Federal agencies that fund cancer research. Other trials may be eligible for coverage and doctors can ask Medicare to pay the patients’ costs. Ask your doctor about this before you begin.

·

They are designed to treat or diagnose your cancer.

·

The purpose or subject of the trial is within a Medicare benefit category. For example, cancer diagnosis and treatment are Medicare benefits, so these trials are covered. Cancer prevention trials are not currently covered.

Increasing the Likelihood of Insurance Coverage for Trials23 There are several steps you can follow to deal with coverage issues up front when deciding to enter a clinical trial. Along the way, enlist the help of family members and your doctor or other health professionals. You may find the following checklist useful:

Understand the Costs Associated with the Trial Ask your doctor or the trial’s contact person about the costs that must be covered by you or your health plan. Are these costs significantly higher than those associated with standard care? Also, inquire about the experience of other patients in the trial. Have their plans paid for their care? Have there been any persistent problems with coverage? How often have the trial’s administrators been successful in getting plans to cover patient care costs?

Understand Your Health Plan Be sure you know what’s in your policy; request and carefully review the actual contract language. If there’s a specific exclusion for “experimental treatment,” look closely at the policy to see how the plan defines such treatment and under what conditions it might be covered. If it is not clearly defined, call the plan’s customer service line, consult their Web site, and/or write to them. Ask for specific information about clinical trials coverage.

This section has been adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=0df4397a-eccb-465f-bd33-a89e7a708c46. 23


Work Closely with Your Doctor Talk with your doctor about the paperwork he or she submits to your health plan. If there have been problems with coverage in the past, you might ask your doctor or the hospital to send an information package to the plan that includes studies supporting the procedure’s safety, benefits, and medical appropriateness. This package might include: ·

Publications from peer-reviewed literature about the proposed therapy that demonstrate patient benefits;

·

A letter that uses the insurance contract’s own language to explain why the treatment, screening method, or preventive measure should be covered;

·

Letters from researchers that explain the clinical trial;

·

Support letters from patient advocacy groups.

Be sure to keep your own copy of any materials that the doctor sends to your health plan for future reference.

Work Closely with Your Company’s Benefits Manager This person may be helpful in enlisting the support of your employer to request coverage by the health plan.

Give Your Health Plan a Deadline Ask the hospital or cancer center to set a target date for the therapy. This will help to ensure that coverage decisions are made promptly.

Know Your Rights24 A number of state governments are addressing the question of whether insurance companies ought to cover the costs associated with patients’ participation in clinical trials. Lack of such coverage is a significant barrier to many patients who might otherwise benefit from enrolling in a trial. Lack of coverage also makes it harder for researchers to successfully conduct trials that could improve prevention and treatment options. Information on State 24

Adapted from Cancer.gov: http://www.cancer.gov/ClinicalTrials/insurancelaws.

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initiatives and legislation concerning cancer-related clinical trials is available at http://www.cancer.gov/ClinicalTrials/insurancelaws. By conducting your own research and learning about your rights, you may increase the likelihood that your insurance company will cover the costs of a trial.

What If An Insurance Claim Is Denied after the Trial Has Begun? If a claim is denied, read your policy to find out what steps you can follow to make an appeal. In “What Cancer Survivors Need to Know about Health Insurance”, the National Coalition for Cancer Survivorship suggests that you and your doctor demonstrate to the health plan that: ·

The therapy is not just a research study, but also a valid procedure that benefits patients;

·

Your situation is similar to that of other patients who are participating in clinical trials as part of a covered benefit;

·

Possible complications have been anticipated and can be handled effectively.

You also may wish to contact your state insurance counseling hotline or insurance department for more help, or write your state insurance commissioner describing the problem.

Where Else Can I Turn for Assistance? It’s never easy to deal with financial issues when you or a loved one faces cancer. Unfortunately, costs can present a significant barrier to clinical trials participation. The range of insurance issues and health plan contracts makes it impossible to deal with all of them here. You may wish to consult this partial list of publications, organizations, and Web sites for more information: Publications What Cancer Survivors Need to Know about Health Insurance National Coalition of Cancer Survivorship 1010 Wayne Avenue, 5th floor


Silver Spring, MD 20910 (301) 650-8868 http://www.cansearch.org/ Cancer Treatments Your Insurance Should Cover The Association of Community Cancer Centers 11600 Nebel Street, Suite 201 Rockville, MD 20852 (301) 984-9496 http://www.accc-cancer.org/main2001.shtml The Managed Care Answer Guide Patient Advocate Foundation 739 Thimble Shoals Boulevard, Suite 704 Newport News, VA 23606 (757) 873-6668 E-mail: [email protected] 1998 Guide to Health Insurance for People with Medicare, The Medicare Handbook Medicare Helpline: 1-800-444-4606 Health Care Financing Administration: http://www.hcfa.gov/ New Medicare site: http://www.medicare.gov/ Assistance Programs Candlelighters Childhood Cancer Foundation Ombudsman Program 910 Woodmont Avenue, #4607 Bethesda, MD 20814 (301) 657-8401; 1-800-366-2223 (toll-free) E-mail: [email protected] http://www.candlelighters.org The Ombudsman Program helps families of children with cancer and survivors of childhood cancer resolve a range of problems, including insurance coverage difficulties. Local groups appoint a Parent Advocate who works with the treatment center on behalf of families. Medical Care Management Corporation 5272 River Road, Suite 650 Bethesda, MD 20816-1405 (301) 652-1818

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email: [email protected] http://www.mcman.com/ Working for a range of clients, including health plans, employers, and patients, MCMC conducts independent, objective reviews of hightechnology medical care cases to assist in decision-making. While it does charge for its services, MCMC also offers a volunteer program for those who cannot afford to pay. More Information Resources OncoLink A service of the University of Pennsylvania Cancer Center. http://www.oncolink.com/ In addition to general cancer information, this web site features a section on financial information for patients. Among the topics: viatical settlements, life insurance, a glossary of financial and medical terms, and news about billing and insurance. American Association of Health Plans 1129 20th Street, NW, Suite 600 Washington, DC 20036-3421 (202) 778-3200 http://www.aahp.org/ The Web site section “For Consumers” includes a fact sheet on clinical research that describes various health plans’ efforts to support research initiatives and collaborate with academic health centers and universities. Health Insurance Association of America 555 13th Street, NW Washington, DC 20004 (202) 824-1600 ·

Home page: http://www.hiaa.org/

·

Consumer Information: http://www.hiaa.org/consumer/

·

Insurance Counseling Hotlines by State: http://www.hiaa.org/consumer/insurance_counsel.cfm

·

State Insurance Departments: http://www.hiaa.org/consumer/state_insurance.cfm


Government Initiatives to Expand Insurance Coverage for Trials25 The good news is that there has been a recent effort in the U.S. to assure clinical trials coverage, with NCI involved in several new initiatives as described below: NCI-Department of Defense Agreement An innovative 1996 agreement between NCI and the Department of Defense (DoD) has given thousands of DoD cancer patients more options for care and greater access to state-of-the-art treatments. Patients who are beneficiaries of TRICARE/CHAMPUS, the DoD’s health program, are covered for NCIsponsored Phase II and Phase III clinical treatment trials. NCI and DoD are refining a system that allows physicians and patients to determine quickly what current trials meet their needs and where they are taking place. NCI-Department of Veterans Affairs Agreement A 1997 agreement with the Department of Veterans Affairs provides coverage for eligible veterans of the armed services to participate in NCIsponsored prevention, diagnosis, and treatment studies nationwide. For additional information, see the VA/DoD Beneficiaries Digest Page at http://www.va.gov/cancer.htm.

Midwest Health Plans Agreement Some NCI Cooperative Groups have reached agreements with several insurers in Wisconsin and Minnesota to provide more than 200,000 people with coverage. This coverage is allocated for patient care costs if they participate in a cooperative group-sponsored trial.

Adapted from the NCI: http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=1d92be79-8748-4bda-80052a56d332463b&docid=d8092601-daf9-4794-8536-3be2712eb6b9. 25

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Pediatric Cancer Care Network This network, a cooperative agreement among the Children’s Cancer Group, the Pediatric Oncology Group, and the Blue Cross Blue Shield System Association (BCBS) nationwide, will ensure that children of BCBS subscribers receive care at designated centers of cancer care excellence and may promote the enrollment of children in Cooperative Group clinical trials.

Keeping Current on Clinical Trials Various government agencies maintain databases on trials. The U.S. National Institutes of Health, through the National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and physicians with current information about clinical research across the broadest number of diseases and conditions. The site was launched in February 2000 and currently contains approximately 5,700 clinical studies in over 59,000 locations worldwide, with most studies being conducted in the United States. ClinicalTrials.gov receives about 2 million hits per month and hosts approximately 5,400 visitors daily. To access this database, simply go to their Web site (www.clinicaltrials.gov) and search by “Kaposi’s sarcoma” (or synonyms). While ClinicalTrials.gov is the most comprehensive listing of NIH-supported clinical trials available, not all trials are in the database. The database is updated regularly, so clinical trials are continually being added. The following is a list of specialty databases affiliated with the National Institutes of Health that offer additional information on trials: ·

For clinical studies at the Warren Grant Magnuson Clinical Center located in Bethesda, Maryland, visit their Web site: http://clinicalstudies.info.nih.gov/

·

For clinical studies conducted at the Bayview Campus in Baltimore, Maryland, visit their Web site: http://www.jhbmc.jhu.edu/studies/index.html

·

For cancer trials, visit the National Cancer Institute: http://cancertrials.nci.nih.gov/


General References The following references describe clinical trials and experimental medical research. They have been selected to ensure that they are likely to be available from your local or online bookseller or university medical library. These references are usually written for healthcare professionals, so you may consider consulting with a librarian or bookseller who might recommend a particular reference. The following includes some of the most readily available references (sorted alphabetically by title; hyperlinks provide rankings, information and reviews at Amazon.com): ·

A Guide to Patient Recruitment : Today’s Best Practices & Proven Strategies by Diana L. Anderson; Paperback - 350 pages (2001), CenterWatch, Inc.; ISBN: 1930624115; http://www.amazon.com/exec/obidos/ASIN/1930624115/icongroupinterna

·

A Step-By-Step Guide to Clinical Trials by Marilyn Mulay, R.N., M.S., OCN; Spiral-bound - 143 pages Spiral edition (2001), Jones & Bartlett Pub; ISBN: 0763715697; http://www.amazon.com/exec/obidos/ASIN/0763715697/icongroupinterna

·

The CenterWatch Directory of Drugs in Clinical Trials by CenterWatch; Paperback - 656 pages (2000), CenterWatch, Inc.; ISBN: 0967302935; http://www.amazon.com/exec/obidos/ASIN/0967302935/icongroupinterna

·

The Complete Guide to Informed Consent in Clinical Trials by Terry Hartnett (Editor); Paperback - 164 pages (2000), PharmSource Information Services, Inc.; ISBN: 0970153309; http://www.amazon.com/exec/obidos/ASIN/0970153309/icongroupinterna

·

Dictionary for Clinical Trials by Simon Day; Paperback - 228 pages (1999), John Wiley & Sons; ISBN: 0471985961; http://www.amazon.com/exec/obidos/ASIN/0471985961/icongroupinterna

·

Extending Medicare Reimbursement in Clinical Trials by Institute of Medicine Staff (Editor), et al; Paperback 1st edition (2000), National Academy Press; ISBN: 0309068886; http://www.amazon.com/exec/obidos/ASIN/0309068886/icongroupinterna

·

Handbook of Clinical Trials by Marcus Flather (Editor); Paperback (2001), Remedica Pub Ltd; ISBN: 1901346293; http://www.amazon.com/exec/obidos/ASIN/1901346293/icongroupinterna

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Vocabulary Builder The following vocabulary builder gives definitions of words used in this chapter that have not been defined in previous chapters: Angiogenesis: Blood vessel formation. Tumor angiogenesis is the growth of blood vessels from surrounding tissue to a solid tumor. This is caused by the release of chemicals by the tumor. [NIH] Anthracycline: A member of a family of anticancer drugs that are also antibiotics. [NIH] Antigens: Substances that cause the immune system to make a specific immune response. [NIH] Antiviral: Destroying viruses or suppressing their replication. [EU] Assay: Determination of the amount of a particular constituent of a mixture, or of the biological or pharmacological potency of a drug. [EU] Bacteria: A large group of single-cell microorganisms. Some cause infections and disease in animals and humans. The singular of bacteria is bacterium. [NIH]

Biopsy: The removal of cells or tissues for examination under a microscope. When only a sample of tissue is removed, the procedure is called an incisional biopsy or core biopsy. When an entire tumor or lesion is removed, the procedure is called an excisional biopsy. When a sample of tissue or fluid is removed with a needle, the procedure is called a needle biopsy or fineneedle aspiration. [NIH] Bleomycin: An anticancer drug that belongs to the family of drugs called antitumor antibiotics. [NIH] Carcinoma: Cancer that begins in the skin or in tissues that line or cover internal organs. [NIH] Catheter: A flexible tube used to deliver fluids into or withdraw fluids from the body. [NIH] Chronic: A disease or condition that persists or progresses over a long period of time. [NIH] CSF: Cerebrospinal fluid. The fluid flowing around the brain and spinal cord. CSF is produced in the ventricles of the brain. [NIH] Cutaneous: Having to do with the skin. [NIH] Cytotoxic: Cell-killing. [NIH] Didanosine: A drug used to treat infection caused by viruses. [NIH] Doxorubicin: An anticancer drug that belongs to the family of drugs called antitumor antibiotics. It is an anthracycline. [NIH]


Effusion: The escape of fluid into a part or tissue, as an exudation or a transudation. [EU] Endemic: Present or usually prevalent in a population or geographical area at all times; said of a disease or agent. Called also endemial. [EU] Epithelial: Refers to the cells that line the internal and external surfaces of the body. [NIH] Etoposide: An anticancer drug that is a podophyllotoxin derivative and belongs to the family of drugs called mitotic inhibitors. [NIH] Fibrosarcoma: A type of soft tissue sarcoma that begins in fibrous tissue, which holds bones, muscles, and other organs in place. [NIH] Filgrastim: A colony-stimulating factor that stimulates the production of neutrophils (a type of white blood cell). It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called granulocyte colony-stimulating factor (G-CSF). [NIH] Gastric: Having to do with the stomach. [NIH] Gastrointestinal: Refers to the stomach and intestines. [NIH] Gland: An organ that produces and releases one or more substances for use in the body. Some glands produce fluids that affect tissues or organs. Others produce hormones or participate in blood production. [NIH] Granulocyte: A type of white blood cell that fights bacterial infection. Neutrophils, eosinophils, and basophils are granulocytes. [NIH] Granulocytopenia: A deficiency in the number of granulocytes, a type of white blood cell. [NIH] Hepatitis: Inflammation of the liver. [NIH] Herpes: Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of clusters of small vesicles. When used alone, the term may refer to herpes simplex or to herpes zoster. [EU] Herpesviridae: A family of enveloped, linear, double-stranded DNA viruses infecting a wide variety of animals. There are three subfamilies based on biological characteristics: Alphaherpesvirinae, Betaherpesvirinae, and Gammaherpesvirinae. [NIH] Histocompatibility: The degree of antigenic similarity between the tissues of different individuals, which determines the acceptance or rejection of allografts. [NIH] Immunity: The condition of being immune; the protection against infectious disease conferred either by the immune response generated by immunization or previous infection or by other nonimmunologic factors (innate i.). [EU] Infusion: A method of putting fluids, including drugs, into the bloodstream.

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Also called intravenous infusion. [NIH] Interferons: Proteins secreted by vertebrate cells in response to a wide variety of inducers. They confer resistance against many different viruses, inhibit proliferation of normal and malignant cells, impede multiplication of intracellular parasites, enhance macrophage and granulocyte phagocytosis, augment natural killer cell activity, and show several other immunomodulatory functions. [NIH] Leiomyosarcoma: A tumor of the muscles in the uterus, abdomen, or pelvis. [NIH]

Leukemia: Cancer of blood-forming tissue. [NIH] Liposomal: A drug preparation that contains the active drug in very tiny fat particles. This fat-encapsulated drug is absorbed better, and its distribution to the tumor site is improved. [NIH] Lymphedema: A condition in which excess fluid collects in tissue and causes swelling. It may occur in the arm or leg after lymph vessels or lymph nodes in the underarm or groin are removed or treated with radiation. [NIH] Lymphocyte: A white blood cell. Lymphocytes have a number of roles in the immune system, including the production of antibodies and other substances that fight infection and diseases. [NIH] Lymphoma: Cancer that arises in cells of the lymphatic system. [NIH] Macrophage: A type of white blood cell that surrounds and kills microorganisms, removes dead cells, and stimulates the action of other immune system cells. [NIH] Melanoma: A form of skin cancer that arises in melanocytes, the cells that produce pigment. Melanoma usually begins in a mole. [NIH] Metabolite: process. [EU]

Any substance produced by metabolism or by a metabolic

Metastatic: Having to do with metastasis, which is the spread of cancer from one part of the body to another. [NIH] Mitoxantrone: An anticancer drug that belongs to the family of drugs called antitumor antibiotics. [NIH] MRI: Magnetic resonance imaging (mag-NET-ik REZ-o- nans IM-a-jing). A procedure in which a magnet linked to a computer is used to create detailed pictures of areas inside the body. [NIH] Myelotoxic: 1. Destructive to bone marrow. 2. Arising from diseased bone marrow. [EU] Necrosis: Refers to the death of living tissues. [NIH] Neutropenia: An abnormal decrease in the number of neutrophils, a type of white blood cell. [NIH]


Neutrophil: A type of white blood cell. [NIH] Paclitaxel: An anticancer drug that belongs to the family of drugs called mitotic inhibitors. [NIH] Pharmacokinetics: The activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted. [NIH] Progression: Increase in the size of a tumor or spread of cancer in the body. [NIH]

Proteins: Polymers of amino acids linked by peptide bonds. The specific sequence of amino acids determines the shape and function of the protein. [NIH]

Randomized: Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. [NIH] Recombinant: A cell or an individual with a new combination of genes not found together in either parent; usually applied to linked genes. [EU] Recurrence: The return of cancer, at the same site as the original (primary) tumor or in another location, after the tumor had disappeared. [NIH] Refractory: Not readily yielding to treatment. [EU] Regimen: A treatment plan that specifies the dosage, the schedule, and the duration of treatment. [NIH] Remission: A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although there still may be cancer in the body. [NIH] Rhabdomyosarcoma: A malignant tumor of muscle tissue. [NIH] Ritonavir: A drug that belongs to the family of drugs called protease inhibitors. It interferes with the ability of a virus to make copies of itself. [NIH] Sargramostim: A colony-stimulating factor that stimulates the production of blood cells, especially platelets, during chemotherapy. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called GM-CSF. [NIH] Serum: The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed. [NIH] Sputum: Mucus coughed up from the lungs. [NIH] Squamous: Scaly, or platelike. [EU] SU5416: An anticancer drug that belongs to the family of drugs called angiogenesis inhibitors. [NIH] Subcutaneous: Beneath the skin. [NIH]

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Synergistic: Acting together; enhancing the effect of another force or agent. [EU]

Thermal: Pertaining to or characterized by heat. [EU] Tolerance: 1. The ability to endure unusually large doses of a drug or toxin. 2. Acquired drug tolerance; a decreasing response to repeated constant doses of a drug or the need for increasing doses to maintain a constant response. [EU]

Tomography: A series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine. [NIH] Toxicity: The quality of being poisonous, especially the degree of virulence of a toxic microbe or of a poison. [EU] Vincristine: An anticancer drug that belongs to the family of plant drugs called vinca alkaloids. [NIH] Viruses: Minute infectious agents whose genomes are composed of DNA or RNA, but not both. They are characterized by a lack of independent metabolism and the inability to replicate outside living host cells. [NIH] Zalcitabine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication at low concentrations, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal toxic side effect is axonal degeneration resulting in peripheral neuropathy. [NIH] Zidovudine: A drug that inhibits the human immunodeficiency virus (HIV) that causes AIDS. Also called AZT. [NIH]

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PART II: ADDITIONAL RESOURCES AND ADVANCED MATERIAL

ABOUT PART II In Part II, we introduce you to additional resources and advanced research on Kaposi’s sarcoma. All too often, patients who conduct their own research are overwhelmed by the difficulty in finding and organizing information. The purpose of the following chapters is to provide you an organized and structured format to help you find additional information resources on Kaposi’s sarcoma. In Part II, as in Part I, our objective is not to interpret the latest advances on Kaposi’s sarcoma or render an opinion. Rather, our goal is to give you access to original research and to increase your awareness of sources you may not have already considered. In this way, you will come across the advanced materials often referred to in pamphlets, books, or other general works. Once again, some of this material is technical in nature, so consultation with a professional familiar with Kaposi’s sarcoma is suggested.

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CHAPTER 4. STUDIES ON KAPOSI’S SARCOMA Overview Every year, academic studies are published on Kaposi’s sarcoma or related conditions. Broadly speaking, there are two types of studies. The first are peer reviewed. Generally, the content of these studies has been reviewed by scientists or physicians. Peer-reviewed studies are typically published in scientific journals and are usually available at medical libraries. The second type of studies is non-peer reviewed. These works include summary articles that do not use or report scientific results. These often appear in the popular press, newsletters, or similar periodicals. In this chapter, we will show you how to locate peer-reviewed references and studies on Kaposi’s sarcoma. We will begin by discussing research that has been summarized and is free to view by the public via the Internet. We then show you how to generate a bibliography on Kaposi’s sarcoma and teach you how to keep current on new studies as they are published or undertaken by the scientific community.

The Combined Health Information Database The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and Kaposi’s sarcoma, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the


format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type in “Kaposi’s sarcoma” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box.

Federally Funded Research on Kaposi’s Sarcoma The U.S. Government supports a variety of research studies relating to Kaposi’s sarcoma and associated conditions. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.26 CRISP (Computerized Retrieval of Information on Scientific Projects) is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Visit the CRISP Web site at http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen. You can perform targeted searches by various criteria including geography, date, as well as topics related to Kaposi’s sarcoma and related conditions. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore Kaposi’s sarcoma and related conditions. In some cases, therefore, it may be difficult to understand how some basic or fundamental research could eventually translate into medical practice. The following sample is typical of the type of information found when searching the CRISP database for Kaposi’s sarcoma: ·

Project Title: ANTIGENS OF KAPOSI'S SARCOMA ASSOCIATED HERPESVIRUS Principal Investigator & Institution: Chandran, Bala; Professor; Microbiology; University of Kansas Medical Center; Kansas City, KS 66103 Timing: Fiscal Year 2002; Project Start 1-APR-1998; Project End 1-JAN2007

26 Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).

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Summary: (Provided by the applicant): The AIDS-defining illness Kaposi's sarcoma (KS) and several lines of evidences suggest that Kaposi's sarcoma-associated herpesvirus (KSHV) or HHV-8 is vital for KS pathogenesis. The long-term objective of this research is to examine the role of HHV-8 in the pathogenesis of KS. Serological studies conducted in the last funding period suggest that HHV-8 lytic replication precedes AIDS-KS. To determine the role of lytic replication in KS pathogenesis, the focus of the present study is on HHV-8 binding and entry interactions with host cells, with a rationale that these interactions per se may have a role in the pathogenesis of KS. In vitro and in vivo, HHV-8 has a broad tropism. Our studies show that this broad cellular tropism may be in part due to HHV-8's interaction with the ubiquitous host cell surface heparin sulfate (HS)-like molecules. HHV-8 envelope glycoprotein gB interacts with HS and rabbit anti-gB antibodies neutralized HHV-8 infection. Sequence analyses show that among the HHV-8 glycoproteins, and among all the gB of human and animal herpesviruses sequenced to date, only HHV-8 gB possesses the "RGD" (Arg-Gly-Asp) amino acids in the extracellular domain. The "RGD" amino acids is the minimal peptide region of many proteins known to interact with host cell integrins critical for the regulation of gene expression, cellular growth and differentiation. We hypothesize that HHV-8 envelope glycoprotein gB interaction with host cell surface integrins may play a vital role in the biology of HHV-8 infection and in the pathogenesis of HHV-8 associated KS. To examine this hypothesis, four major specific aims have been formulated: (1) To determine whether HHV-8 recognize host cell surface integrin molecules (2) To determine the role of integrins in HHV-8 interactions with host cells (3) To determine the interactions between HHV-8 gB and the cell surface integrins. (4) To determine the morphological and molecular consequences of HHV-8 and HHV-8 gB interactions with cell surface integrins. These studies are significant since they will provide an insight into the biology of HHV-8 and it's role in the pathogenesis of KS. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: BIOLOGICAL STUDIES IN KAPOSI'S SARCOMA Principal Investigator & Institution: Browning, Philip J.; Assistant Professor; Medicine; Vanderbilt University; 2101 W End Ave; Nashville, TN 37240 Timing: Fiscal Year 2000; Project Start 30-SEP-1999; Project End 9-SEP2002 Summary: (adapted from the investigator's abstract) Since early in the AIDS epidemic, HIV-infected individuals have higher incidence rates of Kaposi's sarcoma (ICS) than HIV-1 infected age-matched controls.


Among HIV-infected individuals with KS, a clinical staging system presented unique challenges because of the multifocal presentation without a defined primary site, and because the severity of HIV-infection independently influences the growth and proliferation of KS spindle cells. We recently identified circulating cells that shared phenotypic and functional properties with the spindle cells of KS lesions. The cells were high inpatients with KS and HIV-infected individuals at highest risk to develop KS. Moreover, we recently discovered that these cells are infected with the proposed etiologic agent of KS, human herpesvirus 8 (HHV-8) and that transcripts for a viral homologue of cellular cyclin D are found in these cells. These findings led us to the following hypothesis that will be tested as part of a multi-institutional Eastern Cooperative Oncology Group A1DS-KS Phase III study evaluating Paclitaxel versus liposomal Doxorubicin in Advanced AIDS-associated KS. The working hypothesis to be tested is that Kaposi's sarcoma initiation requires human herpesvirus 8 infection of an endothelial progenitor cell. In specific aim 1, `we will quantitate the number of endothelial progenitor cells cultured from AIDS-KS patients before therapy and determine if this number has Prognostic value in assessing survival and response to therapy. Peripheral blood mononuclear cells will be cultured using defined culture conditions and the number of VE-cadherin+CD34+ cells will be determined after 10 days in culture. These values will be compared with CD4 lymphocyte count and extent of skin lesions. In aim 2, we will determine if the increased numbers of endothelial progenitors before therapy correlate with a high baseline HIV viral load. In the third aim, we will utilize a well-characterized HHV-8 v-cyclin D antibody to identify HHV-8-infected cells in the peripheral blood of AIDS-KS patients. strategy will be used to determine if the infected cells are stem cells or lineage committed cells. The results from these studies will advance our knowledge of KS pathogenesis, HHV-8 viral tropism, and hopefully improve our staging and ability to monitor AIDS-KS disease response. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: COL-3 IN PATIENTS WITH HIV RELATED KAPOSI'S SARCOMA Principal Investigator & Institution: Kaplan, Lawrence; University of California, San Francisco; 500 Parnassus Ave; San Francisco, CA 94122 Timing: Fiscal Year 2000; Project Start 1-OCT-1974; Project End 30-NOV2002 Summary: Col-3 is a modified tetracycline matrix metalloproteinases inhibitor that has been shown to stop tumor growth by interfering with angiogenesis. Vascular endothelial proliferation and rapid formation of

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new blood vessels is integral to the pathophysiology of Kaposi's sarcoma. Therefore, agents that inhibit angiogenesis could be potentially useful in treating Kaposi's sarcoma. This is a phase I dose escalating study of Col-3 administered orally on a continuous once daily dosing schedule. Single and multiple-dose pharmacokinetic evaluations will be performed on all subjects on days 1 and 29 of treatment. The GCRC will be used as the site for the pharmacokinetic evaluations. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: DOSE ESCALATING STUDY OF CUTANEOUS AIDS RELATED KAPOSI'S SARCOMA Principal Investigator & Institution: Miles, Steven; University of California, Los Angeles; Box 951361, 405 Hilgard Ave; Los Angeles, CA 90095 Timing: Fiscal Year 2000 Summary: Primary objective is to evaluate the safety and tolerability of escalating doses of SU5416 in patients with AIDS-related Kaposi's Sarcoma. The secondary objectives are to establish the pharmacokinetics of systemic HIV therapies in patients with AIDS-related Kaposi's Sarcoma; and to evaluate the anti-tumor effects of SU5416 in patients with AIDS-related Kaposi's Sarcoma. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen

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Project Title: HHV8 VIRAL LOAD IN KAPOSI'S SARCOMA Principal Investigator & Institution: Quinlivan, Byrd J.; University of North Carolina, Chapel Hill; Box 2688, 910 Raleigh Rd; Chapel Hill, NC 27515 Timing: Fiscal Year 2000 Summary: The purpose of this research study is to help determine the cause(s) of Kaposi's sarcoma by analyzing Kaposi's sarcoma tissue. These analyses will include measurements of the effect of a substance (Tat) produced by Human Immunodeficiency Virus infected cells on Kaposi's sarcoma. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen

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Project Title: KAPOSI'S SARCOMA ASSOCIATED HERPESVIRUS ENCODED NUCLEAR Principal Investigator & Institution: Ballestas, Mary E.; Brigham and Women's Hospital; 75 Francis St; Boston, MA 02115 Timing: Fiscal Year 2000; Project Start 1-APR-2000; Project End 1-MAR2005


Summary: The Kaposi's sarcoma-associated herpesvirus (KSHV) or human herpesvirus-8 is associated with malignancies such as Kaposi's sarcoma, primary effusion lymphoma (PEL), and multicentric Castleman's disease. These tumors primarily occur in immune suppressed individuals, including organ transplant recipients and AIDS patients. In infected cells, KSHV is primarily latent and the viral DNA is maintained as a multiple copy extrachromosomal element or episome. KSHV latency-associated nuclear antigen (LANA) colocalizes with mitotic chromosomes and KSHV DNA. LANA is required for KSHV DNA with a specific cis-acting sequence to persist as an episome in infected cells. This data is consistent with LANA tethering KSHV episomes to chromosomes to mediate efficient segregation of KSHV episomes to progeny cells. Recent work shows that LANA is phosphorylated. The objectives of this proposal are (i) to characterize LANA's phosphorylation status in KSHV infected cells, (ii) to define the residues of LANA that are phosphorylated; (iii) to assess the effect of phosphorylation on LANA's functions. These experiments may identify targets for pharmacological intervention in the treatment of Kaposi's sarcoma and KSHV-associated malignancies. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: NOVEL THERAPY FOR KAPOSI'S SARCOMA Principal Investigator & Institution: Larrick, James W.; President and Scientific Director; Panorama Research, Inc.; 2462 Wyandotte St; Mountain View, CA 94043 Timing: Fiscal Year 2000; Project Start 4-FEB-2000; Project End 1-JUL-2000 Summary: The present application is based on the remarkable finding that a four amino acid extension of a human ribonuclease, eosinophilderived neurotoxin [EDN(-4)], accounts for much of the cytotoxic activity of crude human chorionic gonadotropin for Kaposi's sarcoma cells . The overall goal of this work is to produce rhEDN(-4) in the chloroplasts of transgenic plants as an abundant source of material for further investigations and clinical development. The rationale for this approach is the finding that previous efforts to express the protein in heterologous systems generate a fully processed hEDN which is devoid of anti-KS cytotoxic activity. Chloroplasts offer a sequestered site, relatively free of signal peptidases, wherein high-level protein expression can be achieved. In phase I we will a) construct chloroplast expression vectors for rhEDN(4); b) optimize rhEDN(-4) production in tobacco plants; c) evaluate in vitro activity of plant produced rhEDN(-4) and d) evaluate anti-tumor activity of rhEDN(- 4) in a KS-immunodeficient mouse model. Phase II studies of toxicology, GMP production and expanded animal efficacy will

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be carried out to support filing an IND. rhEDN(-4) may offer a novel, specific, non-toxic therapy for Kaposi's sarcoma and other disorders of angiogenesis. PROPOSED COMMERCIAL APPLICATIONS: The market for an effective agent for Kaposi's sarcoma and other disorders of angiogenesis is substantial. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: VIRAL LYSIS OF KAPOSI'S SARCOMA TUMOR CELLS Principal Investigator & Institution: Sun, Ren; Assistant Professor; Molecular & Med Pharmacology; University of California, Los Angeles; Box 951361, 405 Hilgard Ave; Los Angeles, CA 90095 Timing: Fiscal Year 2001; Project Start 1-APR-2001; Project End 1-MAR2005 Summary: (Provided by the Applicant) Kaposi's sarcoma (KS) is the most frequently occurring intraoral malignancy in AIDS patients. KS tumor cells are infected by human herpesvirus-8/Kaposi's sarcoma associated herpesvirus (HHV-8/KSHV). HHV-8 virions are shed into the saliva of AIDS patients. Herpesviruses exhibit two distinct life cycle phases, latency and lytic replication. Viral latency is directly associated with the proliferation of infected cells with limited viral gene expression and is refractory to any antiviral drugs. Most tumor cells in Kaposi's sarcoma lesions are infected by HHV-8 in the latent phase. During the lytic phase, or upon reactivation from latency, expression of all viral genes produces virions and results in death of the host cell, meanwhile providing targets for antiviral drugs such as Gancyclovir. A viral immediate-early gene, Rta, the replication and transcription activator of HHV-8, was recently identified by Dr. Sun. Rta is necessary and sufficient for disrupting latency and initiation of HHV-8 lytic replication. Furthermore, Rta can autostimulate its own gene expression, and is therefore a sensitive molecular switch in the HHV-8 life cycle. Dr. Sun's study of Rta leads him to propose the hypothesis that intentional induction of lytic replication of HHV-8 in KS tumor cells will lead to lysis of infected tumor cells and destruction of the tumor lesion. The specific aims of his proposal are: 1) to further define the mechanism controlling the expression of Rta; and 2) to develop multiple approaches to induce HHV8 lytic replication of HHV-8 and lysis of KS tumor cells in the presence of Gancyclovir. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen


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Project Title: HIV 1 TATS PROMOTION OF KAPOSIS SARCOMA Principal Investigator & Institution: Samaniego, Felipe C.; Assistant Professor; Clinical Cancer Prevention; University of Texas; Anderson Cancer Center; Houston, TX 77030 Timing: Fiscal Year 2000; Project Start 1-AUG-1999; Project End 1-AUG2003 Summary: (Applicant's Description): The Principal Investigator plans to develop his intellectual and analytical skills to become a successfully funded independent investigator. A program of didactic and laboratory training in virology and mentoring by senior investigators with expertise in virology and immunology will be used. The long term goal of the PI is to establish himself as a nationally recognized investigator in Human herpesvirus 8 [HHV8]-Kaposi's sarcoma biology. The presence of either human immunodeficiency virus (HIV-1) or HHV8 alone is not associated with a high frequency of Kaposi's sarcoma. Their combined presence, however, leads to frequent development of KS. The applicants' hypothesis is that the high frequency and aggressiveness of KS in HIV-Iinfected individuals is due to a direct effect of HIV-I Tat on cells or HHV8. Preliminary studies show Tat signals through binding to cell surface integrin receptors through its RGD integrin binding motif in a manner that mimics the integrin ligands, fibronectin and vitronectin. The investigators will test for activation of focal adhesion kinase (FAK) and involvement of the integrin-FAK- Ras-MAP kinase signaling pathway by blockade at steps along the integrin pathway and the use of dominant negative mutants of ras. Further studies will employ single exon Tat, which is still competent for trans-activation of the HIV-1 promoter, but lacks the RGD motif, versus full length Tat. Initial studies have shown that Tat activates HHV8 replication in vitro. Tat transgenic mice will be used for studies on whether Tat also promotes HHV8 replication in vivo. The elucidation of the effects of Tat on integrin- dependent cell signaling, and HHV8 replication will provide insights into HIV- 1 pathogenesis in KS and could lead to the identification of sites for intervention in the commonest cancer seen in HIV-1 infected people. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen

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Project Title: KAPOSI SARCOMA ASSOCIATED HERPESVIRUS PATHOGENESIS Principal Investigator & Institution: Jung, Jae U.; Associate Professor; Microbiol & Molecular Genetics; Harvard University; Medical School Campus; Boston, MA 02115 Timing: Fiscal Year 2000; Project Start 5-JUN-1999; Project End 1-MAR2003

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Summary: Kaposi's sarcoma (KS) is a multi-focal vascular tumor of mixed cellular composition that is the most common neoplasm in patients with acquired immunodeficiency syndrome (AIDS). A new member of the herpesvirus group, Kaposi's sarcoma-associated herpesvirus (KSHV) or human herpesvirus * (HHV8), has been consistently identified in KS, body cavity-based lymphoma and some forms of Castleman's disease. Although still limited, the presently available data provide compelling evidence that KSHV is the long-sought infectious cause of KS. Analysis of KSHV genomic sequences has revealed that KSHV is a gamma herpesvirus that is closely related to herpesvirus saimiri (HVS) of New World primates and to the recently isolated rhesus rhadinovirus (RRV). The proposed work is directed toward understand the molecular mechanisms of KSHV associated pathogenesis. To define the role of KSHV genes in cell activation, transformation in vitro, and disease induction in vivo, we propose to use recombinant strains of HVS where selected KSHV gene are substituted for specific HVS genes. Because of the lack of cell culture systems and animal models for KSHV infection and the high degree of similarity in genetic information of KSHV to HVS, this approach provides a unique opportunity to investigate the contribution of individual KSHV genes to lymphocyte transformation in vitro and lymphoma induction in vivo. Using this approach, we have already identified K1 as an oncogene of KSHV capable of replacing the STP oncogene of HVS. The viral interferon regulatory factor (vIRF) functions as a repressor for cellular anti-viral activity and tumor suppressor activity. Detailed studies of the K1 transforming gene and vIRF of KSHV will be performed to understand their functional roles in the alteration of cellular signal transduction and transformation. The proposed studies will increase our understanding of individual KSHV genes in the disease associated with the virus. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: KSHV TRANSFORMATION AND ANGIOGENESIS IN KAPOSIS SARCOMA Principal Investigator & Institution: Cesarman, Ethel; Associate Professor; Pathology; Weill Medical College of Cornell University; New York, NY 10021 Timing: Fiscal Year 2000; Project Start 1-APR-1999; Project End 1-MAR2002 Summary: Kaposi's sarcoma-associated herpesvirus (KSHV), or human herpesvirus 8 (HHV 8), is invariably present in Kaposi's sarcoma (KS) lesions where it has been localized in the endothelial cells as well as in the spindle cells, which are thought to be of endothelial cell origin. We


have been able to reproducibly infect primary human endothelial cells with KSHV, and obtained apparently immortalized endothelial cell cultures as a direct result of this infection. The KSHV-infected endothelial cells are transformed as defined by their anchorage independent growth, prolonged survival and telomerase activity. This provides the first direct demonstration that KSHV is an oncogenic virus, and probably represents the best in vitro system developed thus far to study the pathobiology of Kaposi's sarcoma. However, the mechanism of transformation utilized by KSHV appears to be different from that of other oncogenic viruses, since only a small proportion of the cells in these cultures retain the viral genome. Preliminary evidence has suggested that paracrine mechanisms play an important role in the long term survival induced by KSHV, but that the viral genome is necessary for full transformation. Our overall objective is to test this hypothesis by using in vitro infection of endothelial cells to analyze the mechanism(s) of transformation of endothelial cells by KSHV and the role of angiogenesis in this process. Specifically, we plan: (Aim number 1 )to characterize the paracrine mechanisms responsible for the long term survival of endothelial cells; (Aim number 2) to assess the direct effect of KSHV in transformation; (Aim number 3) to assess the HIV/KSHV interactions in endothelial cell cultures, and (Aim number 4) to develop a mouse model for the study of KS. The results of these experiments should allow us to better understand the process of infection and transformation by KSHV. The information gained will contribute to our understanding of the pathogenesis of Kaposis sarcoma, and will aid in the development of rational therapeutic and preventive approaches. These studies will also provide information that will enrich our general knowledge of viral oncogenesis. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen ·

Project Title: THE ROLE OF T1.1 RNA IN KSHV REPLICATION Principal Investigator & Institution: Hagen, Moira; Medicine; University of Colorado; Health Sciences Center; 4200 E 9Th Ave; Denver, Co 80262 Timing: Fiscal Year 2001; Project Start 1-MAY-2001 Summary: (Provided by the applicant): Kaposi's sarcoma is the most commonly occurring cancer in persons infected with human immunodeficiency virus (HIV) and the acquired immunodeficiency syndrome (AIDS). Recent studies have provided strong evidence that Kaposi's sarcoma herpesvirus (KSHV or HHV-8) is the causative agent of Kaposi's sarcoma. To date, little is known about the detailed molecular biology of KSHV replication and pathogenesis. The purpose of the studies in this proposal is to understand the function of KSHV T1.1 RNA. Based on the hypothesis that T1.1 RNA is important for KSHV

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replication, it is important to know if it affects vira1 gene expression. It is also important to determine if T1.1 RNA directly interacts with viral or host cellular proteins. To address these questions, chemical modification mapping studies of the T1.1 RNA will determine accessible regions and identify on potential RNA protein binding motifs. This information will be used to design hammerhead ribozymes or anti-sense oligonucleotides that efficiently inhibit T1.1 RNA function. Affinity purification methods based on the T1.1 RNA mapping patterns will be used to identify cellular or viral proteins that form the T1.1 ribonucleoprotein complex. Website: http://commons.cit.nih.gov/crisp3/Crisp_Query.Generate_Screen

E-Journals: PubMed Central27 PubMed Central (PMC) is a digital archive of life sciences journal literature developed and managed by the National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medicine (NLM).28 Access to this growing archive of e-journals is free and unrestricted.29 To search, go to http://www.pubmedcentral.nih.gov/index.html#search, and type “Kaposi’s sarcoma” (or synonyms) into the search box. This search gives you access to full-text articles. The following is a sample of items found for Kaposi’s sarcoma in the PubMed Central database: ·

Activation of NF-[kappa]B by the Human Herpesvirus 8 Chemokine Receptor ORF74: Evidence for a Paracrine Model of Kaposi's Sarcoma Pathogenesis by Shibani Pati, Marielle Cavrois, Hong-Guang Guo, James S. Foulke, Jr., Jynho Kim, Ricardo A. Feldman, and Marvin Reitz; 2001 September 15 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=115111

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Anti-Kaposi's Sarcoma and Antiangiogenic Activities of Sulfated Dextrins by Mark Thornton, Laura Barkley, Justin C. Mason, and Sunil Shaunak; 1999 October http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=89514

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Cultured Kaposi's sarcoma tumor cells exhibit a chemokine receptor repertoire that does not allow infection by HIV-1 by Thierry Simonart,

Adapted from the National Library of Medicine: http://www.pubmedcentral.nih.gov/about/intro.html. 28 With PubMed Central, NCBI is taking the lead in preservation and maintenance of open access to electronic literature, just as NLM has done for decades with printed biomedical literature. PubMed Central aims to become a world-class library of the digital age. 29 The value of PubMed Central, in addition to its role as an archive, lies the availability of data from diverse sources stored in a common format in a single repository. Many journals already have online publishing operations, and there is a growing tendency to publish material online only, to the exclusion of print. 27


Claire Debussher, Corinne Liesnard, Laurent Debaisieux, Marie-Luce Delforge, Aurore de Lavareille, Philippe Hermans, Jean-Paul Van Vooren, and Patrick Stordeur; 2001 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=37541 ·

Evidence for multiclonality in multicentric Kaposi's sarcoma by Parkash S. Gill, Yvonne C. Tsai, Adupa P. Rao, Charles H. Spruck, III, Tong Zheng, William A. Harrington, Jr., Tony Cheung, Bharat Nathwani, and Peter A. Jones; 1998 July 7 http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=20963

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Human Immunodeficiency Virus Tat Modulates the Flk-1/KDR Receptor, Mitogen-Activated Protein Kinases, and Components of Focal Adhesion in Kaposi's Sarcoma Cells by Ramesh K. Ganju, Neru Munshi, B. C. Nair, Zhong-Ying Liu, Parkash Gill, and Jerome E. Groopman; 1998 July http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=110419

The National Library of Medicine: PubMed One of the quickest and most comprehensive ways to find academic studies in both English and other languages is to use PubMed, maintained by the National Library of Medicine. The advantage of PubMed over previously mentioned sources is that it covers a greater number of domestic and foreign references. It is also free to the public.30 If the publisher has a Web site that offers full text of its journals, PubMed will provide links to that site, as well as to sites offering other related data. User registration, a subscription fee, or some other type of fee may be required to access the full text of articles in some journals. To generate your own bibliography of studies dealing with Kaposi’s sarcoma, go to the PubMed Web site at www.ncbi.nlm.nih.gov/pubmed. Type “Kaposi’s sarcoma” (or synonyms) into the search box, and click “Go.” The following is the type of output you can expect from PubMed for “Kaposi’s sarcoma” (hyperlinks lead to article summaries): ·

A case of Kaposi's sarcoma associated with pemphigoid nodularis. Author(s): Gao XH, Lin J, Yang C, Ma L, Wang G, Wang Y, Chen HD.

30 PubMed was developed by the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The PubMed database was developed in conjunction with publishers of biomedical literature as a search tool for accessing literature citations and linking to full-text journal articles at Web sites of participating publishers. Publishers that participate in PubMed supply NLM with their citations electronically prior to or at the time of publication.

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Source: J Dermatol. 2001 July; 28(7): 388-92. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11510508&dopt=Abstract ·

A Lack of Clinical Correlation between the Presence of HHV-8 DNA in PBMCs and Staging of Kaposi's Sarcoma. Author(s): Edelman DC, Sill A. Source: Dermatology (Basel, Switzerland). 2002; 205(2): 189. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12218244&dopt=Abstract

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A unique case of a benign disseminated angioproliferation combining features of Kaposi's sarcoma and diffuse dermal angioendotheliomatosis. Author(s): Kunstfeld R, Petzelbauer P. Source: Journal of the American Academy of Dermatology. 2001 October; 45(4): 601-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11568754&dopt=Abstract

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Actinomycin D-mediated sensitization of AIDS-Kaposi's sarcoma cells to Fas-mediated apoptosis: involvement of the mitochondrion-dependent pathway. Author(s): Mori S, Murakami-Mori K, Nakamura S, Bonavida B. Source: International Journal of Oncology. 2002 April; 20(4): 819-26. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11894131&dopt=Abstract

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Activation of NF-kappaB by the human herpesvirus 8 chemokine receptor ORF74: evidence for a paracrine model of Kaposi's sarcoma pathogenesis. Author(s): Pati S, Cavrois M, Guo HG, Foulke JS Jr, Kim J, Feldman RA, Reitz M. Source: Journal of Virology. 2001 September; 75(18): 8660-73. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11507211&dopt=Abstract

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Aggressive Kaposi's sarcoma in a 6-month-old African infant: case report and review of the literature. Author(s): Manji KP, Amir H, Maduhu IZ. Source: Tropical Medicine & International Health : Tm & Ih. 2000 February; 5(2): 85-7. No Abstract Available.


http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12303944&dopt=Abstract ·

AIDS and non-AIDS-related malignancies: a new vexing challenge in HIVpositive patients. Part I: Kaposi's sarcoma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. Author(s): Spano JP, Atlan D, Breau JL, Farge D. Source: European Journal of Internal Medicine. 2002 May; 13(3): 170-179. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12020624&dopt=Abstract

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AIDS-associated Kaposi's sarcoma: a rare entity at Maharaj Nakorn Chiang Mai Hospital. Author(s): Khunamornpong S, Bhoopat L, Vithayasai P, Pruksachatkunakorn C. Source: Asian Pac J Allergy Immunol. 1996 December; 14(2): 115-20. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12251988&dopt=Abstract

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AIDS-related Kaposi's sarcoma with chylothorax and pericardial involvement satisfactorily treated with liposomal doxorubicin. Author(s): Maradona JA, Carton JA, Asensi V, Rodriguez-Guardado A. Source: Aids (London, England). 2002 March 29; 16(5): 806. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11964546&dopt=Abstract

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Anaplastic transformation of classic Kaposi's sarcoma: clinicopathological study of five cases. Author(s): Satta R, Cossu S, Massarelli G, Cottoni F. Source: The British Journal of Dermatology. 2001 November; 145(5): 8479. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11736920&dopt=Abstract

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Angiogenic effects of extracellular human immunodeficiency virus type 1 Tat protein and its role in the pathogenesis of AIDS-associated Kaposi's sarcoma. Author(s): Barillari G, Ensoli B.

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Source: Clinical Microbiology Reviews. 2002 April; 15(2): 310-26. Review. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11932235&dopt=Abstract ·

Association between Kaposi's sarcoma and atherosclerosis: implications for gammaherpesviruses and vascular disease. Author(s): Grahame-Clarke C, Alber DG, Lucas SB, Miller R, Vallance P. Source: Aids (London, England). 2001 September 28; 15(14): 1902-4. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11579262&dopt=Abstract

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Bilateral adrenal Kaposi's sarcoma in an HIV seronegative patient. Author(s): Lazure T, Plantier F, Alsamad IA, Cabanis P, Malaury E, Blondeau JR. Source: The Journal of Urology. 2001 November; 166(5): 1822-3. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11586233&dopt=Abstract

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Cancers associated with Kaposi's sarcoma (KS) in AIDS: a link between KS herpesvirus and immunoblastic lymphoma. Author(s): Engels EA, Rosenberg PS, Frisch M, Goedert JJ. Source: British Journal of Cancer. 2001 November 2; 85(9): 1298-303. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11720464&dopt=Abstract

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Case report: Kaposi's sarcoma: an unusual presentation. Author(s): Young AC, Mazzullo JM, Simon AR, Skolnik PR. Source: Medgenmed [electronic Resource] : Medscape General Medicine. 2001 September 28; 3(4): 8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11698915&dopt=Abstract

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Changing incidence of Kaposi's sarcoma and non-Hodgkin's lymphoma among young men in San Francisco. Author(s): Clarke CA. Source: Aids (London, England). 2001 September 28; 15(14): 1913-5. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11579268&dopt=Abstract


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Classic Kaposi's sarcoma associated with human herpesvirus 8 infection in a 13-year-old male: a case report. Author(s): Landau HJ, Poiesz BJ, Dube S, Bogart JA, Weiner LB, Souid AK. Source: Clinical Cancer Research : an Official Journal of the American Association for Cancer Research. 2001 August; 7(8): 2263-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11489800&dopt=Abstract

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Classic Kaposi's sarcoma of the tongue: case report with emphasis on the differential diagnosis. Author(s): Reis-Filho JS, Souto-Moura C, Lopes JM. Source: J Oral Maxillofac Surg. 2002 August; 60(8): 951-4. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12149747&dopt=Abstract

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Classic type of Kaposi's sarcoma and human herpesvirus 8 infection in Xinjiang, China. Author(s): Dilnur P, Katano H, Wang ZH, Osakabe Y, Kudo M, Sata T, Ebihara Y. Source: Pathology International. 2001 November; 51(11): 845-52. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11844050&dopt=Abstract

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Clearance of human herpesvirus 8 from blood and regression of leukopeniaassociated aggressive classic Kaposi's sarcoma during interferon-alpha therapy: a case report. Author(s): Monini P, Sirianni MC, Franco M, Vincenzi L, Topino S, Goletti D, Leone P, Leone P, Chiozzini C, Nicastri E, Andreoni M, Borduagni O, Sgadari C, Rezza G, Sturzl M, Ensoli B. Source: Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America. 2001 November 15; 33(10): 1782-5. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11641829&dopt=Abstract

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Clinicopathologic study of Kaposi's sarcoma and strain analysis of human herpesvirus 8 (HHV-8) DNA in the Hua-Lien area of eastern Taiwan. Author(s): Hsu YH, Kuo WL, Su IJ. Source: J Formos Med Assoc. 2001 July; 100(7): 449-54. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11579609&dopt=Abstract

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Complete remission of AIDS/Kaposi's sarcoma after treatment with a combination of two nucleoside reverse transcriptase inhibitors and one nonnucleoside reverse transcriptase inhibitor. Author(s): Murdaca G, Campelli A, Setti M, Indiveri F, Puppo F. Source: Aids (London, England). 2002 January 25; 16(2): 304-5. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11807324&dopt=Abstract

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Cultured Kaposi's sarcoma tumor cells exhibit a chemokine receptor repertoire that does not allow infection by HIV-1. Author(s): Simonart T, Debussher C, Liesnard C, Debaisieux L, Delforge ML, de Lavareille A, Hermans P, Van Vooren JP, Stordeur P. Source: Bmc Dermatology [electronic Resource]. 2001; 1(1): 2. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11518547&dopt=Abstract

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Detection of tyrosinase mRNA in tumor tissue microdissections from classic Kaposi's sarcoma. Author(s): Palmieri G, Cossu A, Lissia A, Leoncini L, Lazzi S, Ascierto PA, Castello G, Tanda F. Source: Annals of Oncology : Official Journal of the European Society for Medical Oncology / Esmo. 2001 December; 12(12): 1765-6. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11843258&dopt=Abstract

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Development of Kaposi's sarcoma at the site of a biopsy. Author(s): Yarchoan R, Davis DA. Source: The New England Journal of Medicine. 2002 September 5; 347(10): 763-4; Discussion 763-4. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12213952&dopt=Abstract

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Development of Kaposi's sarcoma in a surgical wound. Author(s): Webster-Cyriaque J. Source: The New England Journal of Medicine. 2002 April 18; 346(16): 1207-10. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11961149&dopt=Abstract


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Direct correlation between human herpesvirus-8 seroprevalence and classic Kaposi's sarcoma incidence in Northern Sardinia. Author(s): Santarelli R, De Marco R, Masala MV, Angeloni A, Uccini S, Pacchiarotti R, Montesu MA, Satta R, Cerimele D, Faggioni A, Cottoni F. Source: Journal of Medical Virology. 2001 October; 65(2): 368-72. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11536246&dopt=Abstract

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Effect of highly active antiretroviral therapy on survival in patients with AIDS-associated pulmonary Kaposi's sarcoma treated with chemotherapy. Author(s): Holkova B, Takeshita K, Cheng DM, Volm M, Wasserheit C, Demopoulos R, Chanan-Khan A. Source: Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. 2001 September 15; 19(18): 3848-51. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11559722&dopt=Abstract

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Efficacy of cidofovir on human herpesvirus 8 viraemia and Kaposi's sarcoma progression in two patients with AIDS. Author(s): Mazzi R, Parisi SG, Sarmati L, Uccella I, Nicastri E, Carolo G, Gatti F, Concia E, Andreoni M. Source: Aids (London, England). 2001 October 19; 15(15): 2061-2. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11600842&dopt=Abstract

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Efficacy of Low-Dose Interferon with Antiretroviral Therapy in Kaposi's Sarcoma: A Randomized Phase II AIDS Clinical Trials Group Study. Author(s): Krown SE, Li P, Von Roenn JH, Paredes J, Huang J, Testa MA. Source: Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research. 2002 March; 22(3): 295-303. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12034036&dopt=Abstract

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Elevated virus loads of Kaposi's sarcoma-associated human herpesvirus 8 predict Kaposi's sarcoma disease progression, but elevated levels of human immunodeficiency virus type 1 do not. Author(s): Quinlivan EB, Zhang C, Stewart PW, Komoltri C, Davis MG, Wehbie RS. Source: The Journal of Infectious Diseases. 2002 June 15; 185(12): 1736-44.

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Enhancement of classic Kaposi's sarcoma growth after intralesional injections of desferrioxamine. Author(s): Simonart T, Boelaert JR, Van Vooren JP. Source: Dermatology (Basel, Switzerland). 2002; 204(4): 290-2. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12077524&dopt=Abstract

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Esophageal and gastric Kaposi's sarcomas presenting as upper gastrointestinal bleeding. Author(s): Lin CH, Hsu CW, Chiang YJ, Ng KF, Chiu CT. Source: Chang Gung Med J. 2002 May; 25(5): 329-33. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12141706&dopt=Abstract

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Etiology and pathogenesis of Kaposi's sarcoma. Author(s): Nickoloff BJ, Foreman KE. Source: Recent Results Cancer Res. 2002; 160: 332-42. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12079231&dopt=Abstract

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Excision of 1,674 classic Kaposi's sarcomas. Author(s): Weintraub CM, Skudowitz RB. Source: S Afr J Surg. 2002 May; 40(2): 80. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12162235&dopt=Abstract

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Expression of the fibroblast/macrophage marker 1B10 by spindle cells in Kaposi's sarcoma lesions and by Kaposi's sarcoma-derived tumor cells. Author(s): Simonart T, Degraef C, Heenen M, Hermans P, Van Vooren JP, Noel JC. Source: Journal of Cutaneous Pathology. 2002 February; 29(2): 72-8. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12150136&dopt=Abstract

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Factors predictive of disease progression and death in AIDS-related Kaposi's sarcoma. Author(s): Spano JP, Salhi Y, Costagliola D, Rozenbaum W, Girard PM. Source: Hiv Medicine. 2000 October; 1(4): 232-7.



Frequent presence of a novel herpesvirus genome in lesions of human immunodeficiency virus-negative Kaposi's sarcoma. Author(s): Chuck S, Grant RM, Katongole-mbidde E, Conant M, Ganem D. Source: The Journal of Infectious Diseases. 1996 January; 173(1): 248-51. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12302787&dopt=Abstract

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HHV-8 DNA in Blood and the Development of HIV-associated Kaposi's Sarcoma in the Era of HAART: A Prospective Evaluation. Author(s): Lorenzen T, Albrecht D, Paech V, Meyer T, Hoffmann C, Stoehr A, Degen O, Stellbrink HJ, Meigel WN, Arndt R, Plettenberg A. Source: European Journal of Medical Research. 2002 June 28; 7(6): 283-6. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12117665&dopt=Abstract

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High incidence of classic Kaposi's sarcoma in Mantua, Po Valley, Northern Italy (1989-1998). Author(s): Ascoli V, Belli S, Benedetti M, Trinca S, Ricci P, Comba P. Source: British Journal of Cancer. 2001 August 3; 85(3): 379-82. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11487269&dopt=Abstract

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HIV-1-Tat protein activates phosphatidylinositol 3-kinase/ AKT-dependent survival pathways in Kaposi's sarcoma cells. Author(s): Deregibus MC, Cantaluppi V, Doublier S, Brizzi MF, Deambrosis I, Albini A, Camussi G. Source: The Journal of Biological Chemistry. 2002 July 12; 277(28): 25195202. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11994280&dopt=Abstract

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Human chorionic gonadotropin inhibits Kaposi's sarcoma associated angiogenesis, matrix metalloprotease activity, and tumor growth. Author(s): Pfeffer U, Bisacchi D, Morini M, Benelli R, Minghelli S, Vacca A, Noonan DM, Albini A.

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Source: Endocrinology. 2002 August; 143(8): 3114-21. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12130577&dopt=Abstract ·

Human herpesvirus 8 (HHV-8) and the etiopathogenesis of Kaposi's sarcoma. Author(s): Leao JC, Caterino-De-Araujo A, Porter SR, Scully C. Source: Revista Do Hospital Das Clinicas. 2002 July-August; 57(4): 175-86. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12244338&dopt=Abstract

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Human herpesvirus 8 (HHV-8) detected in two patients with Kaposi's sarcoma-like pyogenic granuloma. Author(s): Ryan P, Aarons S, Murray D, Markham T, O'Sullivan S, Lyons F, Lee G, Fitzgibbon J. Source: Journal of Clinical Pathology. 2002 August; 55(8): 619-22. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12147659&dopt=Abstract

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Human herpesvirus 8 cytoviraemia rebound in a patient with Kaposi's sarcoma after a short interruption of efficient antiretroviral therapy. Author(s): Parisi SG, Mazzi R, Sarmati L, Carolo G, Uccella I, Rianda A, Nicastri E, Concia E, Andreoni M. Source: Aids (London, England). 2002 May 3; 16(7): 1089-91. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11953484&dopt=Abstract

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Human herpesvirus 8-derived viral IL-6 induces PTX3 expression in Kaposi's sarcoma cells. Author(s): Klouche M, Brockmeyer N, Knabbe C, Rose-John S. Source: Aids (London, England). 2002 May 24; 16(8): F9-18. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12004288&dopt=Abstract

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Human non-pregnancy ribonuclease with anti-Kaposi's sarcoma activity. Author(s): Al-Owais MM, Hesse L, Talbot SJ, Adams DJ. Source: Cancer Letters. 2002 February 25; 176(2): 183-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11804746&dopt=Abstract


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Influence of HIV epidemic on the incidence of Kaposi's sarcoma in Zambian children. Author(s): Athale UH, Patil PS, Chintu C, Elem B. Source: J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 8(1): 96-100. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12159477&dopt=Abstract

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Interleukin 8 is an autocrine growth factor and a surrogate marker for Kaposi's sarcoma. Author(s): Masood R, Cai J, Tulpule A, Zheng T, Hamilton A, Sharma S, Espina BM, Smith DL, Gill PS. Source: Clinical Cancer Research : an Official Journal of the American Association for Cancer Research. 2001 September; 7(9): 2693-702. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11555581&dopt=Abstract

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Interleukin-8 and Growth-Regulated Oncogene Alpha Mediate Angiogenesis in Kaposi's Sarcoma. Author(s): Lane BR, Liu J, Bock PJ, Schols D, Coffey MJ, Strieter RM, Polverini PJ, Markovitz DM. Source: Journal of Virology. 2002 November 15; 76(22): 11570-11583. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12388718&dopt=Abstract

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Is AIDS an epidemic form of African Kaposi's sarcoma?: discussion paper. Author(s): Weber J. Source: Journal of the Royal Society of Medicine. 1984 July; 77(7): 572-6. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12301394&dopt=Abstract

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Is volcanic soil a cofactor for classic Kaposi's sarcoma? Author(s): Montella M, Serraino D, Crispo A, Rezza G, Carbone S, Tamburini M. Source: European Journal of Epidemiology. 2000; 16(12): 1185-6. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11484811&dopt=Abstract

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Kaposi's sarcoma and cytomegaloviral ileocolitis complicating long-standing Crohn's disease in an HIV-negative patient. Author(s): Cohen RL, Tepper RE, Urmacher C, Katz S.

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Source: The American Journal of Gastroenterology. 2001 October; 96(10): 3028-31. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11693345&dopt=Abstract ·

Kaposi's sarcoma and human herpesvirus 8 infection do not protect HIV-1 infected homosexual men from AIDS dementia complex. Author(s): Renwick N, Weverling GJ, Halaby T, Portegies P, Bakker M, Schulz TF, Goudsmit J. Source: Aids (London, England). 2001 November 9; 15(16): 2165-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11684936&dopt=Abstract

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Kaposi's sarcoma and Pneumocystis pneumonia among homosexual men-New York City and California. Author(s): Friedman-kien A, Laubenstein L, Marmor M, Hymes K, Green J, Ragaz A, Gottleib J, Muggia F, Demopoulos R, Weintraub M. Source: Mmwr. Morbidity and Mortality Weekly Report. 1981 July 3; 30(25): 305-8. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12248460&dopt=Abstract

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Kaposi's Sarcoma and Transplantation. Author(s): Mendez JC, Paya CV. Source: Herpes : the Journal of the Ihmf. 2000 February; 7(1): 18-23. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11866996&dopt=Abstract

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Kaposi's sarcoma associated herpesvirus (KSHV) or human herpesvirus 8 (HHV8). Author(s): Schulz TF, Sheldon J, Greensill J. Source: Virus Research. 2002 January 30; 82(1-2): 115-26. Review. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11885938&dopt=Abstract

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Kaposi's sarcoma associated herpesvirus immune evasion strategies. Author(s): Means RE, Lang SM, Chung YH, Jung JU. Source: Frontiers in Bioscience : a Journal and Virtual Library. 2002 May 1; 7: E185-203. Review.



Kaposi's sarcoma associated with previous human herpesvirus 8 infection in heart transplant recipients. Author(s): Emond JP, Marcelin AG, Dorent R, Milliancourt C, Dupin N, Frances C, Agut H, Gandjbakhch I, Calvez V. Source: Journal of Clinical Microbiology. 2002 June; 40(6): 2217-9. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12037090&dopt=Abstract

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Kaposi's sarcoma biology. Author(s): Boshoff C. Source: Iubmb Life. 2002 April-May; 53(4-5): 259-61. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12121006&dopt=Abstract

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Kaposi's sarcoma in a patient with focal glomerulosclerosis. Author(s): Zerbi S, Saruggia M, Brambilla L, Lodeville D, Buccianti G. Source: J Nephrol. 2001 July-August; 14(4): 299-303. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11506254&dopt=Abstract

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Kaposi's sarcoma in an elderly patient with rheumatoid arthritis after intraarticular corticosteroids. Author(s): Burnet SP, McNeil JD. Source: Rheumatology (Oxford, England). 2002 January; 41(1): 107-8. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=11792889&dopt=Abstract

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Kaposi's sarcoma in an Indian woman infected with HIV-1 and HIV-2. Author(s): Rubsamen-waigmann H, Grez M, Von Briesen H, Dietrich U, Shroff HJ, Kaaya EE, Biberfeld P. Source: Aids Research and Human Retroviruses. 1993 June; 9(6): 573-7. No Abstract Available. http://www.ncbi.nlm.nih.gov:80/entrez/query.fcgi?cmd=Retrieve&db= PubMed&list_uids=12299376&dopt=Abstract

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Vocabulary Builder Acetylcysteine: A drug usually used to reduce the thickness of mucus and ease its removal. It is also used to reverse the toxicity of high doses of acetaminophen. Also called N-acetylcysteine. [NIH] Alleles: Mutually exclusive forms of the same gene, occupying the same locus on homologous chromosomes, and governing the same biochemical and developmental process. [NIH] Antiangiogenic: vessels. [NIH]

Having to do with reducing the growth of new blood

Antibody: A type of protein made by certain white blood cells in response to a foreign substance (antigen). Each antibody can bind to only a specific antigen. The purpose of this binding is to help destroy the antigen. Antibodies can work in several ways, depending on the nature of the antigen. Some antibodies destroy antigens directly. Others make it easier for white blood cells to destroy the antigen. [NIH] Asymptomatic: Having no signs or symptoms of disease. [NIH] Benign: Not cancerous; does not invade nearby tissue or spread to other parts of the body. [NIH] Candidiasis: Infection with a fungus of the genus Candida. It is usually a superficial infection of the moist cutaneous areas of the body, and is generally caused by C. albicans; it most commonly involves the skin (dermatocandidiasis), oral mucous membranes (thrush, def. 1), respiratory tract (bronchocandidiasis), and vagina (vaginitis). Rarely there is a systemic infection or endocarditis. Called also moniliasis, candidosis, oidiomycosis, and formerly blastodendriosis. [EU] Cheilitis: Inflammation of the lips. It is of various etiologies and degrees of pathology. [NIH] Chloroplasts: Plant cell inclusion bodies that contain the photosynthetic pigment chlorophyll, which is associated with the membrane of thylakoids. Chloroplasts occur in cells of leaves and young stems of higher plants. [NIH] Cidofovir: A drug used to treat infection caused by viruses. [NIH] Concomitant: Accompanying; accessory; joined with another. [EU] Corticosteroids: Hormones that have antitumor activity in lymphomas and lymphoid leukemias; in addition, corticosteroids (steroids) may be used for hormone replacement and for the management of some of the complications of cancer and its treatment. [NIH] Cyclosporine: A drug used to help reduce the risk of rejection of organ and bone marrow transplants by the body. It is also used in clinical trials to make


cancer cells more sensitive to anticancer drugs. [NIH] Dementia: An acquired organic mental disorder with loss of intellectual abilities of sufficient severity to interfere with social or occupational functioning. The dysfunction is multifaceted and involves memory, behavior, personality, judgment, attention, spatial relations, language, abstract thought, and other executive functions. The intellectual decline is usually progressive, and initially spares the level of consciousness. [NIH] Drosophila: A genus of small, two-winged flies containing approximately 900 described species. These organisms are the most extensively studied of all genera from the standpoint of genetics and cytology. [NIH] Epitopes: Sites on an antigen that interact with specific antibodies. [NIH] Extracellular: Outside a cell or cells. [EU] FSH: A gonadotropic hormone found in the pituitary tissues of mammals. It regulates the metabolic activity of ovarian granulosa cells and testicular Sertoli cells, induces maturation of Graafian follicles in the ovary, and promotes the development of the germinal cells in the testis. [NIH] Gingivitis: Inflammation of the gingivae. Gingivitis associated with bony changes is referred to as periodontitis. Called also oulitis and ulitis. [EU] Glycoprotein: A protein that has sugar molecules attached to it. [NIH] Granuloma: A relatively small nodular inflammatory lesion containing grouped mononuclear phagocytes, caused by infectious and noninfectious agents. [NIH] Hematopoiesis: The forming of new blood cells. [NIH] Heparin: A drug that helps prevent blood clots from forming. It belongs to the family of drugs called anticoagulants (blood thinners). [NIH] Hydrocortisone: A drug used to relieve the symptoms of certain hormone shortages and to suppress an immune response. [NIH] Hyperplasia: An abnormal increase in the number of cells in an organ or tissue. [NIH] Immunology: The study of the body's immune system. [NIH] Immunosuppression: Suppression of the body's immune system and its ability to fight infections or disease. Immunosuppression may be deliberately induced with drugs, as in preparation for bone marrow or other organ transplantation to prevent rejection of the donor tissue. It may also result from certain diseases such as AIDS or lymphoma or from anticancer drugs. [NIH] Induction: The act or process of inducing or causing to occur, especially the production of a specific morphogenetic effect in the developing embryo through the influence of evocators or organizers, or the production of

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anaesthesia or unconsciousness by use of appropriate agents. [EU] Leukocytes: Cells that help the body fight infections and other diseases. Also called white blood cells (WBCs). [NIH] Leukopenia: A condition in which the number of leukocytes (white blood cells) in the blood is reduced. [NIH] Leukoplakia: A white patch that may develop on mucous membranes such as the cheek, gums, or tongue and may become cancerous. [NIH] Lymphadenopathy: Disease or swelling of the lymph nodes. [NIH] Malignancy: A cancerous tumor that can invade and destroy nearby tissue and spread to other parts of the body. [NIH] Neoplasia: Abnormal and uncontrolled cell growth. [NIH] Neoplasm: A new growth of benign or malignant tissue. [NIH] Neurologic: Having to do with nerves or the nervous system. [NIH] Neurotoxin: A substance that is poisonous to nerve tissue. [NIH] Oncogene: A gene that normally directs cell growth. If altered, an oncogene can promote or allow the uncontrolled growth of cancer. Alterations can be inherited or caused by an environmental exposure to carcinogens. [NIH] Peptide: Any compound consisting of two or more amino acids, the building blocks of proteins. Peptides are combined to make proteins. [NIH] Phosphorylation: The introduction of a phosphoryl group into a compound through the formation of an ester bond between the compound and a phosphorus moiety. [NIH] Pneumonia: An inflammatory infection that occurs in the lung. [NIH] Pyogenic: Producing pus; pyopoietic (= liquid inflammation product made up of cells and a thin fluid called liquor puris). [EU] Receptor: A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell. [NIH] Retroperitoneal: Having to do with the area outside or behind the peritoneum (the tissue that lines the abdominal wall and covers most of the organs in the abdomen). [NIH] Rhadinovirus: A genus of the family Herpesviridae, subfamily Gammaherpesvirinae, infecting New World primates. Herpesvirus 2, Ateline is the type species. [NIH] Sensitization: 1. Administration of antigen to induce a primary immune response; priming; immunization. 2. Exposure to allergen that results in the development of hypersensitivity. 3. The coating of erythrocytes with antibody so that they are subject to lysis by complement in the presence of homologous antigen, the first stage of a complement fixation test. [EU]


Telomerase: Essential ribonucleoprotein reverse transcriptase that adds telomeric DNA to the ends of eukaryotic chromosomes. Telomerase appears to be repressed in normal human somatic tissues but reactivated in cancer, and thus may be necessary for malignant transformation. EC 2.7.7.-. [NIH] Tetracycline: An antibiotic drug used to treat infection. [NIH] Transplantation: person. [NIH]

The replacement of an organ with one from another

Tyrosine: A non-essential amino acid. In animals it is synthesized from phenylalanine. It is also the precursor of epinephrine, thyroid hormones, and melanin. [NIH] Ulcer: A local defect, or excavation, of the surface of an organ or tissue; which is produced by the sloughing of inflammatory necrotic tissue. [EU] Urology: A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes and the genital tract in the male. It includes the specialty of andrology which addresses both male genital diseases and male infertility. [NIH] Vinblastine: An anticancer drug that belongs to the family of plant drugs called vinca alkaloids. It is a mitotic inhibitor. [NIH] Virion: The infective system of a virus, composed of the viral genome, a protein core, and a protein coat called a capsid, which may be naked or enclosed in a lipoprotein envelope called the peplos. [NIH] Xenograft: The cells of one species transplanted to another species. [NIH] Xerostomia: Dryness of the mouth from salivary gland dysfunction, as in Sjögren's syndrome. [EU]

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CHAPTER 5. BOOKS ON KAPOSI’S SARCOMA Overview This chapter provides bibliographic book references relating to Kaposi’s sarcoma. You have many options to locate books on Kaposi’s sarcoma. The simplest method is to go to your local bookseller and inquire about titles that they have in stock or can special order for you. Some patients, however, feel uncomfortable approaching their local booksellers and prefer online sources (e.g. www.amazon.com and www.bn.com). In addition to online booksellers, excellent sources for book titles on Kaposi’s sarcoma include the Combined Health Information Database and the National Library of Medicine. Once you have found a title that interests you, visit your local public or medical library to see if it is available for loan.

Book Summaries: Federal Agencies The Combined Health Information Database collects various book abstracts from a variety of healthcare institutions and federal agencies. To access these summaries, go to http://chid.nih.gov/detail/detail.html. You will need to use the “Detailed Search” option. To find book summaries, use the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer. For the format option, select “Monograph/Book.” Now type “Kaposi’s sarcoma” (or synonyms) into the “For these words:” box. You will only receive results on books. You should check back periodically with this database which is updated every 3 months. The following is a typical result when searching for books on Kaposi’s sarcoma:


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Palate Complaints Source: in Scully, C. Handbook of Oral Disease: Diagnosis and Management. New York, NY: Thieme New York. 2001. p.339-355. Contact: Available from Thieme New York. 333 Seventh Avenue, New York, NY 10001. (212) 760-0888, ext 110. PRICE: $35.00 plus shipping and handling. ISBN: 1841840874. Summary: This chapter on palate complaints is from a handbook of oral disease that is intended to be used by all members of the dental team who need a ready office reference. The handbook covers the more common and important soft tissue orofacial disorders and gives clinically relevant aspects of the etiology, diagnosis, treatment, and prevention. This chapter covers blisters, lumps, red lesions, ulceration, white lesions, adenomatoid hyperplasia, localized oral purpura (angina bullosa hemorrhagica), denture-induced stomatitis, Kaposi's sarcoma, malignant melanoma, papillary hyperplasia (overgrowth), stomatitis nicotina (smoker's palate), and torus palatinus. For each condition, the authors note etiology (cause), diagnosis, symptoms, epidemiology, risk factors, treatment, and prevention (where possible). Much of the information is provided in table or outline format for ease of reference. Full color photographs illustrate some conditions. 24 figures. 9 references.

The National Library of Medicine Book Index The National Library of Medicine at the National Institutes of Health has a massive database of books published on healthcare and biomedicine. Go to the following Internet site, http://locatorplus.gov/, and then select “Search LOCATORplus.” Once you are in the search area, simply type “Kaposi’s sarcoma” (or synonyms) into the search box, and select “books only.” From there, results can be sorted by publication date, author, or relevance. The following was recently catalogued by the National Library of Medicine:31 In addition to LOCATORPlus, in collaboration with authors and publishers, the National Center for Biotechnology Information (NCBI) is adapting biomedical books for the Web. The books may be accessed in two ways: (1) by searching directly using any search term or phrase (in the same way as the bibliographic database PubMed), or (2) by following the links to PubMed abstracts. Each PubMed abstract has a “Books” button that displays a facsimile of the abstract in which some phrases are hypertext links. These phrases are also found in the books available at NCBI. Click on hyperlinked results in the list of books in which the phrase is found. Currently, the majority of the links are between the books and PubMed. In the future, more links will be created between the books and other types of information, such as gene and protein sequences and macromolecular structures. See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Books.

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AIDS, the epidemic of Kaposi's sarcoma and opportunistic infections. Author: edited by Alvin E. Friedman-Kien and Linda J. Laubenstein; Year: 1984; New York: Masson Pub. USA, c1984; ISBN: 0893522171 http://www.amazon.com/exec/obidos/ASIN/0893522171/icongroupin terna

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Clinical pathologic study of Kaposi's sarcoma with particular reference to its relationship to the reticuloendothelial system. Author: Reynolds, William Arthur, 1930-; Year: 1963; [Minneapolis] 1963

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Epidemic of acquired immune deficiency syndrome (AIDS) and Kaposi's sarcoma. Author: First Workshop of the European Study Group on "Epidemic of Acquired Immune Deficiency Syndrome and Kaposi's Sarcoma (AIDS/KS)", Naples, June 25, 1983; volume editors, G. Girald; Year: 1984; Basel; New York: Karger, 1984; ISBN: 3805538766 http://www.amazon.com/exec/obidos/ASIN/3805538766/icongroupin terna

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Kaposi's sarcoma: 2nd Kaposi's Sarcoma Symposium, Kampala, January 8-11, 1980. Author: volume editors, C.L.M. Olweny, M.S.R. Hutt, and R. Owor; Year: 1981; Basel; New York: Karger, 1981; ISBN: 380552076X http://www.amazon.com/exec/obidos/ASIN/380552076X/icongroupi nterna

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Kaposi's sarcoma: a text and atlas. Author: edited by Geoffrey J. Gottlieb, A. Bernard Ackerman; Year: 1988; Philadelphia: Lea & Febiger, 1988; ISBN: 0812110412 http://www.amazon.com/exec/obidos/ASIN/0812110412/icongroupin terna

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Kaposi's sarcoma: pathophysiology and clinical management. Author: edited by John L. Ziegler, Ronald F. Dorfman; Year: 1988; New York: Dekker, c1988; ISBN: 0824778243 http://www.amazon.com/exec/obidos/ASIN/0824778243/icongroupin terna

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Kaposi's sarcoma and related opportunistic infections: hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, Ninety-seventh Congress, second session, April 13, 1982. Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment; Year: 1982; Washington: U.S. G.P.O., 1982

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Kaposi's sarcoma in Illinois: a comparison of AIDS cases to classic cases. Author: authors, Melinda Lehnherr, Holly L. Howe; Year: 1989;


Springfield, Ill.: Illinois Dept. of Public Health, Division of Epidemiologic Studies, [1989] ·

Kaposi's sarcoma in Uganda Africans. Author: Lothe, Francis; Year: 1963; [Oslo] Universitetsforlaget, 1963

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Kaposi's sarcoma. Author: edited by Decio Cerimele; Year: 1985; New York: SP Medical & Scientific Books, c1985; ISBN: 089335208X http://www.amazon.com/exec/obidos/ASIN/089335208X/icongroupi nterna

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Kaposi's sarcoma; multiple idiopathic hemorrhagic sarcoma. Author: Bluefarb, Samuel Mitchell, 1912-; Year: 1957; Springfield, Ill., Thomas [c1957]

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Management of Kaposi's sarcoma associated with human immunodeficiency virus infection: report. Author: prepared by Frances A. Shepherd; Year: 1991; [Ottawa]: Health and Welfare Canada, c1991; ISBN: 0662581415 http://www.amazon.com/exec/obidos/ASIN/0662581415/icongroupin terna

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Recent advances in AIDS and Kaposi's sarcoma. Author: International Workshop on AIDS/Kaposi's Sarcoma, Sorrento, June 2, 1986; volume editors, G. Giraldo ... [et. al.]; Year: 1987; Basel; New York: Karger, 1987; ISBN: 3805545126 http://www.amazon.com/exec/obidos/ASIN/3805545126/icongroupin terna

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Selected abstracts on diagnosis and treatment of Kaposi's sarcoma. Author: John E. Wolf, consulting reviewer; Year: 1983; [Bethesda, Md.]: U.S. Dept. of Health and Human Services, Public Health Service, National Institutes of Health; Springfield, Va.: U.S. Dept. of Commerce, National Technical Information Service [distributor, 1983]

Chapters on Kaposi’s Sarcoma Frequently, Kaposi’s sarcoma will be discussed within a book, perhaps within a specific chapter. In order to find chapters that are specifically dealing with Kaposi’s sarcoma, an excellent source of abstracts is the Combined Health Information Database. You will need to limit your search to book chapters and Kaposi’s sarcoma using the “Detailed Search” option. Go to the following hyperlink: http://chid.nih.gov/detail/detail.html. To find book chapters, use the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Book Chapter.” By making these selections and typing in “Kaposi’s sarcoma” (or synonyms) into the “For these words:” box,

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you will only receive results on chapters in books. The following is a typical result when searching for book chapters on Kaposi’s sarcoma: ·

Intraoral Coloured or Pigmented Lesions Source: in Scully, C. and Cawson, R.A. Oral Disease: Colour Guide. 2nd ed. Edinburgh, Scotland: Churchill Livingstone. 1999. p. 73-88. Contact: Available from W.B. Saunders Company, A Harcourt Health Sciences Company. Book Order Fulfillment Department, 11830 Westline Industrial Drive, St Louis, MO 63146-9988. (800) 545-2522. Fax (800) 5685136. E-mail: [email protected]. Website: www.wbsaunders.com. PRICE: $19.95 plus shipping and handling. ISBN: 044306170X. Summary: This chapter on intraoral colored or pigmented lesions is from a book that is intended as an aid to oral medicine and the diagnosis and treatment of oral disease. The chapter includes 16 full color photographs of intraoral colored or pigmented lesions, with textual information accompanying them. Conditions covered are: hereditary hemorrhagic telangiectasia (HHT), scleroderma (systemic sclerosis), hemangioma, Sturge-Weber syndrome, radiation induced lesions, denture induced stomatitis, erythematous candidosis, erythroplasia (erythroplakia), Kaposi's sarcoma, purpura, racial pigmentation, Peutz-Jeghers syndrome, drug induced hyperpigmentation, amalgam tattoo, pigmented nevi, and malignant melanoma. For each condition, the text briefly covers incidence and etiology, clinical features, diagnosis and diagnostic tests, and treatment options.

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Immunodeficiency Source: in Wray, D., et al. Textbook of General and Oral Medicine. Edinburgh, Scotland: Churchill Livingstone. 1999. p. 273-278. Contact: Available from Harcourt Health Sciences. 11830 Westline Industrial Drive, St. Louis, MO 63146. (800) 325-4177. Fax (800) 874-6418. Website: www.harcourthealth.com. PRICE: $50.00 plus shipping and handling. ISBN: 0443051895. Summary: Immunodeficiency disorders may be classified as either primary or secondary. In general, all are characterized by an increased susceptibility to infections. This chapter on immunodeficiency is from an undergraduate dentistry textbook that covers both general medicine and surgery, and oral medicine, emphasizing the overlap between them. The chapter focuses on HIV disease, including oral lesions associated with HIV infection, such as hairy leukoplakia, Kaposi's sarcoma (KS), non Hodgkin's lymphoma (NHL), periodontal manifestations, HIV associated salivary gland disease, other oral lesions, and the increased risk of oral


carcinoma (cancer) in HIV infected patients. Clinical points to remember are highlighted in text boxes. 8 figures. 3 tables. ·

Oral Manifestations of Human Immunodeficiency Virus Infection Source: in Eisen, D. and Lynch, D.P. Mouth: Diagnosis and Treatment. St. Louis, MO: Mosby, Inc. 1998. p. 237-254. Contact: Available from Harcourt Health Sciences. Book Order Fulfillment Department, 11830 Westline Industrial Drive, St. Louis, MO 63146-9988. Website: www.mosby.com. PRICE: $79.95 plus shipping and handling. ISBN: 0815131054. Summary: The identification of the oral manifestations of HIV (human immunodeficiency virus) infection is of great significance because they may be the first signs of the disease and, furthermore, are highly predictive markers of severe immune deterioration and disease progression. This chapter on the oral manifestations of HIV infection is from a textbook on the mouth that offers information to primary care physicians and to many specialists in medicine and dentistry. The chapter begins with a discussion of the epidemiology of oral manifestations of HIV. The authors then describe how the oral manifestations of AIDS are divided into three groups and discuss each one. Group 1 lesions are strongly associated with HIV infection and include candidiasis, hairy leukoplakia, HIV associated periodontal diseases, Kaposi's sarcoma, and nonHodgkin's lymphoma. Group 2 lesions are less commonly associated with HIV infection and include a variety of bacterial and viral infections, salivary gland dysfunction, and oral mucosal disorders. Group 3 lesions are composed of conditions that have been reported in HIV infected patients but are not strongly linked to either HIV infection or AIDS. The chapter is illustrated with numerous full color photographs of the conditions under discussion. 15 figures. 1 table. 99 references.

General Home References In addition to references for Kaposi’s sarcoma, you may want a general home medical guide that spans all aspects of home healthcare. The following list is a recent sample of such guides (sorted alphabetically by title; hyperlinks provide rankings, information, and reviews at Amazon.com): · Cancer: 50 Essential Things to Do by Greg Anderson, O. Carl Simonton; Paperback - 184 pages; Revised & Updated edition (August 1999), Plume;

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ISBN: 0452280745; http://www.amazon.com/exec/obidos/ASIN/0452280745/icongroupinterna · Cancer Encyclopedia -- Collections of Anti-Cancer & Anti-Carcinogenic Agents, Chemicals, Drugs and Substances by John C. Bartone; Paperback (January 2002), ABBE Publishers Association of Washington, DC; ISBN: 0788326791; http://www.amazon.com/exec/obidos/ASIN/0788326791/icongroupinterna · Cancer Sourcebook: Basic Consumer Health Information About Major Forms and Stages of Cancer by Edward J. Prucha (Editor); Library Binding - 1100 pages, 3rd edition (August 1, 2000), Omnigraphics, Inc.; ISBN: 0780802276; http://www.amazon.com/exec/obidos/ASIN/0780802276/icongroupinterna · Cancer Supportive Care: A Comprehensive Guide for Patients and Their Families by Ernest H. Rosenbaum, M.D., Isadora Rosenbaum, M.A.; Paperback - 472 pages (November 5, 1998), Somerville House Books Limited; ISBN: 1894042115; http://www.amazon.com/exec/obidos/ASIN/1894042115/icongroupinterna · Cancer Symptom Management: Patient Self-Care Guides (Book with CD-ROM for Windows & Macintosh) by Connie Henke Yarbro (Editor), et al; CD-ROM - 264 pages, 2nd Book & CD-Rom edition (January 15, 2000), Jones & Bartlett Publishing; ISBN: 0763711675; http://www.amazon.com/exec/obidos/ASIN/0763711675/icongroupint erna · Diagnosis Cancer: Your Guide Through the First Few Months by Wendy Schlessel Harpham, Ann Bliss Pilcher (Illustrator); Paperback: 230 pages; Revised & Updated edition (November 1997), .W. Norton & Company; ISBN: 0393316912; http://www.amazon.com/exec/obidos/ASIN/0393316912/icongroupinterna · The Human Side of Cancer: Living with Hope, Coping with Uncertainty by Jimmie C. Holland, M.D., Sheldon Lewis; Paperback - 368 pages (October 2, 2001), Quill; ISBN: 006093042X; http://www.amazon.com/exec/obidos/ASIN/006093042X/icongroupintern a

Vocabulary Builder Carcinogenic: Producing carcinoma. [EU] Erythroplakia: mouth. [NIH]

A reddened patch with a velvety surface found in the


Hyperpigmentation: Excessive pigmentation of the skin, usually as a result of increased melanization of the epidermis rather than as a result of an increased number of melanocytes. Etiology is varied and the condition may arise from exposure to light, chemicals or other substances, or from a primary metabolic imbalance. [NIH] Idiopathic: Describes a disease of unknown cause. [NIH] Localization: The process of determining or marking the location or site of a lesion or disease. May also refer to the process of keeping a lesion or disease in a specific location or site. [NIH] Palate: The roof of the mouth. The front portion is bony (hard palate), and the back portion is muscular (soft palate). [NIH] Papillary: Pertaining to or resembling papilla, or nipple. [EU] Pigmentation: 1. The deposition of colouring matter; the coloration or discoloration of a part by pigment. 2. Coloration, especially abnormally increased coloration, by melanin. [EU] Purpura: Purplish or brownish red discoloration, easily visible through the epidermis, caused by hemorrhage into the tissues. [NIH] Scleroderma: A chronic disorder marked by hardening and thickening of the skin. Scleroderma can be localized or it can affect the entire body (systemic). [NIH] Stomatitis: Inflammation of the oral mucosa, due to local or systemic factors which may involve the buccal and labial mucosa, palate, tongue, floor of the mouth, and the gingivae. [EU] Telangiectasia: The permanent enlargement of blood vessels, causing redness in the skin or mucous membranes. [NIH]

Multimedia 139

CHAPTER 6. MULTIMEDIA ON KAPOSI’S SARCOMA Overview Information on Kaposi’s sarcoma can come in a variety of formats. Among multimedia sources, video productions, slides, audiotapes, and computer databases are often available. In this chapter, we show you how to keep current on multimedia sources of information on Kaposi’s sarcoma. We start with sources that have been summarized by federal agencies, and then show you how to find bibliographic information catalogued by the National Library of Medicine. If you see an interesting item, visit your local medical library to check on the availability of the title.

Bibliography: Multimedia on Kaposi’s Sarcoma The National Library of Medicine is a rich source of information on healthcare-related multimedia productions including slides, computer software, and databases. To access the multimedia database, go to the following Web site: http://locatorplus.gov/. Select “Search LOCATORplus.” Once in the search area, simply type in Kaposi’s sarcoma (or synonyms). Then, in the option box provided below the search box, select “Audiovisuals and Computer Files.” From there, you can choose to sort results by publication date, author, or relevance. The following multimedia has been indexed on Kaposi’s sarcoma. For more information, follow the hyperlink indicated: ·

A.I.D.S. is difficult to catch: Kaposi's sarcoma--. Source: University of Wisconsin Cancer Center; producer, Nothing to Hide; David Runyon; Year: 1982; Format: Videorecording; [S.l.]: TOTO Radio; TV Network and Nothing to Hide, 1982


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Kaposi's sarcoma : cutaneous lesions and dermatopathy. Year: 1986; Format: Slide; Washington, D.C.: National Audiovisual Center, [1986]

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Kaposi's sarcoma in acquired immune deficiency syndrome (AIDS). Source: [presented by] Audio-Video Digest Foundation, in collaboration with the University of California, San Francisco, School of Medicine; Year: 1984; Format: Videorecording; Glendale, Calif.: Audio-Video Digest Foundation; University of California, San Francisco, c1984

Vocabulary Builder Pelvic: Pertaining to the pelvis. [EU] Resection: Removal of tissue or part or all of an organ by surgery. [NIH] Thoracic: Having to do with the chest. [NIH]

Physician Guidelines and Databases 141

CHAPTER 7. PHYSICIAN GUIDELINES AND DATABASES Overview Doctors and medical researchers rely on a number of information sources to help patients with their conditions. Many will subscribe to journals or newsletters published by their professional associations or refer to specialized textbooks or clinical guides published for the medical profession. In this chapter, we focus on databases and Internet-based guidelines created or written for this professional audience.

NIH Guidelines For the more common diseases, The National Institutes of Health publish guidelines that are frequently consulted by physicians. Publications are typically written by one or more of the various NIH Institutes. For physician guidelines, commonly referred to as “clinical” or “professional” guidelines, you can visit the following Institutes: ·

Office of the Director (OD); guidelines consolidated across agencies available at http://www.nih.gov/health/consumer/conkey.htm

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National Institute of General Medical Sciences (NIGMS); fact sheets available at http://www.nigms.nih.gov/news/facts/

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National Library of Medicine (NLM); extensive encyclopedia (A.D.A.M., Inc.) with guidelines: http://www.nlm.nih.gov/medlineplus/healthtopics.html

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National Cancer Institute (NCI); guidelines available at http://cancernet.nci.nih.gov/pdq/pdq_treatment.shtml


In this chapter, we begin by reproducing one such guideline for Kaposi’s sarcoma:

What Is Kaposi’s Sarcoma?32 Kaposi’s sarcoma (KS) was first described in 1872 by the Austro-Hungarian dermatologist, Moritz Kaposi. From that time until the current human immunodeficiency virus (HIV) disease epidemic identified with the Acquired Immunodeficiency Syndrome (AIDS), KS remained a rare tumor. While most of the cases seen in Europe and North America have occurred in elderly men of Italian or Eastern European Jewish ancestry, the neoplasm also occurs in several other distinct populations: young black African adult males, prepubescent children, renal allograft recipients, and other patients receiving immunosuppressive therapy. The disseminated, fulminant form of KS associated with HIV disease is referred to as epidemic KS to distinguish it from the classic, African, and transplant-related varieties of the neoplasm. In addition, KS has been identified in homosexual men apart from the HIV disease epidemic.33 Although the histopathology of the different types of the Kaposi’s tumor is essentially identical in all of these groups, the clinical manifestations and course of the disease differ dramatically.34 A key piece to the puzzle of KS pathogenesis was the 1994 discovery of a gamma herpes virus, human herpes virus type 8 (HHV-8), also known as Kaposi’s sarcoma herpes virus.35 HHV-8 was identified in KS tissue biopsies from virtually all patients with classic, African, transplant-related, and AIDS-associated KS, but was absent from non-involved tissue.36

The following guidelines appeared on the NCI website on Aug. 16, 2002. The text was last modified in February 2002. The text has been adapted for this sourcebook. 33 Friedman-Kien AE, Saltzman BR, Cao Y, et al.: Kaposi’s sarcoma in HIV-negative homosexual men. Lancet 335(8682): 168-169, 1990. 34 Safai B: Kaposi’s sarcoma and acquired immunodeficiency syndrome. In: DeVita VT, Hellman S, Rosenberg S, eds.: AIDS: Etiology, Diagnosis, Treatment and Prevention. 4th ed., Philadelphia: Lippincott-Raven Publishers, 1997, pp 295-318. 35 Chang Y, Cesarman E, Pessin MS, et al.: Identification of herpesvirus-like DNA sequences in AIDS-associated Kaposi’s sarcoma. Science 266(5192): 1865-1869, 1994. 36 Moore PS, Chang Y: Detection of herpesvirus-like DNA sequences in Kaposi’s sarcoma in patients with and those without HIV infection. New England Journal of Medicine 332(18): 1181-1185, 1995. Su IJ, Hsu YS, Chang YC, et al.: Herpesvirus-like DNA sequence in Kaposi’s sarcoma from AIDS and non-AIDS patients in Taiwan. Lancet 345(8951): 722-723, 1995. Gao SJ, Kingsley L, Li M, et al.: KSHV antibodies among Americans, Italians and Ugandans with and without Kaposi’s sarcoma. Nature Medicine 2(8): 925-928, 1996. Chang Y, Ziegler J, Wabinga H, et al.: Kaposi’s sarcoma-associated herpesvirus and Kaposi’s sarcoma in Africa. Archives of Internal Medicine 156(2): 202-204, 1996. 32


Classic Kaposi’s Sarcoma Considered a rare disease, classic KS occurs more often in males, with a ratio of approximately 10 to 15 males to 1 female. In North Americans and Europeans, the usual age at onset is between 50 and 70 years of age. Classic KS tumors usually present with 1 or more asymptomatic red, purple, or brown patch, plaque, or nodular skin lesions. The disease is often limited to single or multiple lesions usually localized to 1 or both lower extremities, especially involving the ankle and soles. Classic Kaposi’s sarcoma most commonly runs a relatively benign, indolent course for 10 to 15 years or more with slow enlargement of the original tumors and the gradual development of additional lesions. Venous stasis and lymphedema of the involved lower extremity are frequent complications. In long-standing cases, systemic lesions can develop along the gastrointestinal tract, in lymph nodes, and in other organs. These visceral lesions are generally asymptomatic and are most often discovered only at autopsy, although clinically, gastrointestinal bleeding can occur. Up to one-third of the patients with classic KS develop a second primary malignancy, most often non-Hodgkin’s lymphoma.37

African Kaposi’s Sarcoma In the 1950s, KS was recognized as a relatively common neoplasm endemic in native populations in equatorial Africa, comprising approximately 9% of all cancers seen in Ugandan males. African KS is seen as either an indolent neoplasm identical to the classic disease seen in Europe and North America or as an aggressive disease with fungating and exophytic tumors that may invade the subcutaneous and surrounding tissue including the underlying bone. In Africa, both the indolent and locally more aggressive forms of KS occur with a male to female ratio comparable to that observed with the classic KS tumor seen in North America and Europe. In general, however, patients in Africa are significantly younger than their European counterparts. A lymphadenopathic form of KS is also seen in Africa, primarily in prepubescent children (male:female ratio 3:1). In these cases, the generalized lymphadenopathy is frequently associated with visceral organ 37 Safai B, Good RA: Kaposi’s sarcoma: a review and recent developments. Clinical Bulletin 10(2): 62-69, 1980. Reynolds WA, Winkelmann RK, Soule EH: Kaposi’s sarcoma: a clinicopathologic study with particular reference to its relationship to the reticuloendothelial system. Medicine 44(5): 419-443, 1965. Safai B, Mike V, Giraldo G, et al.: Association of Kaposi’s sarcoma with second primary malignancies: possible etiopathogenic implications. Cancer 45(6): 1472-1479, 1980.


involvement. The prognosis is very poor, with a 100% fatality rate within 3 years.38

Immunosuppressive Treatment-Related Kaposi’s Sarcoma In 1969, the first case of KS in association with immunosuppression in a renal transplant patient was described. Since that time a number of renal and other organ allograft recipients receiving prednisone and azathioprine have developed KS shortly after the onset of immunosuppressive therapy.39 The incidence of KS in immunosuppressed renal transplant recipients has been estimated at between 150 and 200 times the expected incidence of this tumor in the general population. The average time to develop KS after transplantation is about 16 months. Although the tumor in these iatrogenically immunosuppressed patients often remains localized to the skin, widespread dissemination with mucocutaneous or visceral organ involvement is common. In some cases, the KS tumors have regressed as a result of reduction or changes in immunosuppressive therapy. Clinical management of renal transplant patients who develop KS is difficult and requires a balance between the risk of death from generalized KS and the risk of graft rejection and complications of renal failure that may occur if the immunosuppressive therapy is discontinued. Epidemic Kaposi’s Sarcoma In 1981, a fulminant and disseminated form of KS in young homosexual or bisexual men was first reported as part of an epidemic now known as AIDS.40 The etiology of AIDS is a T-cell lymphotropic retrovirus known as HIV. The underlying immunologic deficiency that characterizes HIV disease is an acquired profound disorder of cell-mediated immune functions. This immunologic deficiency and immune dysregulation predisposes the host to a variety of opportunistic infections and unusual neoplasms, especially KS. HIV itself may play an indirect role in the development of KS.41 Taylor JF, Templeton AC, Vogel CL, et al.: Kaposi’s sarcoma in Uganda: a clinicopathological study. International Journal of Cancer 8(1): 122-135, 1971. Templeton AC, Bhana D: Prognosis in Kaposi’s sarcoma. Journal of the National Cancer Institute 55(6): 1301-1304, 1975. 39 Penn I: Kaposi’s sarcoma in organ transplant recipients: report of 20 cases. Transplantation 27(1): 8-11, 1979. 40 Kaposi’s sarcoma and pneumocystis pneumonia among homosexual men: New York City and California. Morbidity and Mortality Weekly Report 30(25): 305-308, 1981. 41 Vogel J, Hinrichs SH, Reynolds RK, et al.: The HIV tat gene induces dermal lesions resembling Kaposi’s sarcoma in transgenic mice. Nature 335(6191): 606-611, 1988. 38


Approximately 95% of all the cases of epidemic KS in the United States have been diagnosed in homosexual or bisexual men. In the past, approximately 26% of all homosexual males with HIV disease presented with, or eventually developed, KS during the course of their illness. By comparison, less than 3% of all heterosexual intravenous drug users with HIV disease developed KS. The proportion of HIV disease patients with KS has steadily decreased since the epidemic was first identified in 1981.42 About 48% of AIDS patients in 1981 had KS as their presenting AIDS diagnosis. By August 1987, the cumulative proportion of AIDS patients with KS had diminished to less than 20%. The introduction of highly active antiretroviral therapy (HAART) may delay or prevent the emergence of drug-resistant HIV strains, profoundly decrease viral load, lead to increased survival, and lessen the risk of opportunistic infections.43 The use of HAART might possibly be related to the continuing downtrend (12%) in the incidence of KS as an AIDS-defining illness. Epidemic KS is usually characterized by multifocal, widespread lesions at the onset of illness.44 These lesions may involve the skin; oral mucosa; lymph nodes; and visceral organs, such as the gastrointestinal tract, lung, liver and spleen. Most patients with HIV disease who present with the mucocutaneous lesions of KS feel healthy and are usually free of systemic symptoms as compared to those patients with HIV disease who first develop an opportunistic infection. The sites of disease at presentation of epidemic KS are much more varied than those seen in the other types of this neoplasm. In an early report on the clinical manifestations of the disease, 49 patients were described.45 Eight percent had no skin involvement, 27% had localized or fewer than 5 skin lesions, and 63% had innumerable skin lesions widely distributed over the skin surface area. Sixty-one percent of the patients had generalized lymphadenopathy at the time of the first examination. Four of these patients who had generalized lymphadenopathy in the absence of skin lesions or detectable visceral organ involvement at the time of presentation were found to have biopsy-proven KS localized to the lymph nodes. In 45% of the patients studied, KS lesions were found in 1 or more sites along the gastrointestinal tract. Twenty-nine percent of the patients had either Selik RM, Starcher ET, Curran JW: Opportunistic diseases reported in AIDS patients: frequencies, associations, and trends. AIDS 1(3): 175-182, 1987. 43 Flexner C: HIV-protease inhibitors. New England Journal of Medicine 338(18): 1281-1292, 1998. Palella FJ, Delaney KM, Moorman AC, et al.: Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine 338(13): 853-860, 1998. 44 Krigel RL, Laubenstein LJ, Muggia FM: Kaposi’s sarcoma: a new staging classification. Cancer Treatment Reports 67(6): 531-534, 1983. 45 Krigel RL, Laubenstein LJ, Muggia FM: Kaposi’s sarcoma: a new staging classification. Cancer Treatment Reports 67(6): 531-534, 1983. 42


unexplained fever or weight loss when first seen. Thus, while most patients present with skin disease, KS involvement of lymph nodes or the gastrointestinal tract may occasionally precede the appearance of the cutaneous lesions. Eventually, almost all patients with epidemic KS develop disseminated disease. Progression often proceeds in an orderly fashion from a few localized or widespread mucocutaneous lesions to more numerous and generalized skin disease with lymph node, gastrointestinal tract disease, and other organ involvement. Pleuropulmonary KS is an ominous sign usually occurring late in the course of the disease, especially in those patients whose death is directly attributed to KS.46 Most patients with epidemic KS die of 1 or more complicating opportunistic infections.

Non-Epidemic Gay-Related Kaposi’s Sarcoma There have been several reports documenting KS in homosexual men who persistently have no evidence of HIV infection. These patients have an indolent and cutaneous form of the disease, with new lesions appearing every few years. Lesions occur most commonly on the extremities and genitalia but can occur anywhere on the skin.47 These cases may indicate the presence of causal factors, other than HIV, that homosexual men may be exposed to due to their lifestyle.

Stage Information The staging evaluation of patients with classic Kaposi’s sarcoma (KS) should be individualized. The advanced age of most of these patients, localized nature of the tumor, rarity of visceral involvement, and usually indolent course of the disease should temper the extent of the evaluation. A careful examination of the skin and lymph nodes is sufficient in most cases. For those unusual patients with rapidly progressive tumor or signs or symptoms of visceral involvement, appropriate evaluation is indicated. There is no universally accepted classification for epidemic KS. Staging schemes have been proposed that incorporate laboratory parameters as well as clinical features. Since most patients with epidemic KS do not die from the disease

Gill PS, Akil B, Colletti P, et al.: Pulmonary Kaposi’s sarcoma: clinical findings and results of therapy. American Journal of Medicine 87(1): 57-61, 1989. 47 Friedman-Kien AE, Saltzman BR, Cao Y, et al.: Kaposi’s sarcoma in HIV-negative homosexual men. Lancet 335(8682): 168-169, 1990. 46


itself, it is apparent that factors besides tumor burden are involved in survival. The conventions used to stage KS and the methods used to evaluate the benefits of KS treatment have been evolving for over a decade in response to changes in the treatment of HIV and in recognition of deficiencies in standard tumor assessment. The clinical course of KS, the selection of treatment, and response to treatment are heavily influenced by the degree of underlying immune dysfunction and opportunistic infections. The AIDS Clinical Trials Group (ACTG) Oncology Committee has published criteria for the evaluation of epidemic KS.48 This staging system incorporates measures of extent of disease, severity of immunodeficiency, and presence of systemic symptoms. As shown below, the ACTG criteria categorizes extent of tumor as localized or disseminated, CD4 cell number as high or low, and systemic illness as absent or present. A subsequent prospective analysis of 294 patients entered on ACTG trials for KS between 1989 and 1995 showed that each of the tumor, immune system, and systemic illness (TIS) variables was independently associated with survival.49 Multivariate analysis showed that immune system impairment was the most important single predictor of survival. In patients with relatively high CD4 counts, tumor stage was predictive. A CD4 count of 150 cells per cubic millimeter may be a better discriminator than the published cut off of 200 cells per cubic millimeter. A study is in progress to determine if viral load adds predictive information. It is important to note that none of the prior studies were conducted at a time when highly active antiretroviral therapy (HAART) was readily available. The impact of HAART on survival in KS will require continued assessment.

48 Krown SE, Metroka C, Wernz JC: Kaposi’s sarcoma in the acquired immune deficiency syndrome: a proposal for uniform evaluation, response, and staging criteria. Journal of Clinical Oncology 7(9): 1201-1207, 1989. 49 Krown SE, Testa MA, et al., for the AIDS Clinical Trials Group Oncology Committee: AIDS-related Kaposi’s sarcoma: prospective validation of the AIDS Clinical Trials Group staging classification. Journal of Clinical Oncology 15(9): 3085-3092, 1997.


AIDS Clinical Trials Group Staging Classification Good Risk (0) (All of the following)

Poor Risk (1) (Any of the following)

Tumor (T)

Confined to skin and/or lymph nodes and/or minimal oral disease*

Tumor-associated edema or ulceration Extensive oral KS Gastrointestinal KS KS in other non-nodal viscera

Immune system (I)

CD4 cells >/= 200/microL

CD4 cells /= 70 (Karnofsky)

History of OI and/or thrush “B” symptoms present Performance status

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