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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075777 |
RATIONALE: Valproic acid may help stop the growth of Kaposi's sarcoma cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This clinical trial is studying valproic acid in treating patients with HIV-related Kaposi's sarcoma.
Condition | Intervention |
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Sarcoma |
Drug: valproic acid |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma |
Estimated Enrollment: | 30 |
Study Start Date: | February 2005 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot, multicenter study.
Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed HIV-related Kaposi's sarcoma (KS)
Disease involving the skin and/or lymph nodes
Slowly progressive or stable disease allowed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0324 | |
Veterans Affairs Medical Center - San Diego | |
San Diego, California, United States, 92161 | |
United States, Georgia | |
Georgia Cancer Center for Excellence at Grady Memorial Hospital | |
Atlanta, Georgia, United States, 30303 | |
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Pennsylvania | |
Joan Karnell Cancer Center at Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19106 | |
United States, Washington | |
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | |
Seattle, Washington, United States, 98111 |
Investigator: | Richard F. Ambinder, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Mary Jo Lechowicz, MD | Georgia Cancer Center for Excellence at Grady Memorial Hospital |
Study ID Numbers: | CDR0000349348, AMC-038 |
Study First Received: | January 9, 2004 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00075777 |
Health Authority: | United States: Federal Government |
recurrent Kaposi sarcoma AIDS-related Kaposi sarcoma |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma Malignant mesenchymal tumor Sarcoma, Kaposi Sarcoma |
DNA Virus Infections Valproic Acid Soft tissue sarcomas Recurrence Herpesviridae Infections |
Neurotransmitter Agents Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Neoplasms Therapeutic Uses Neoplasms, Vascular Tissue GABA Agents Central Nervous System Agents Anticonvulsants |