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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 History of Changes |
Health Authority: | United States: Federal Government |
recurrent Kaposi sarcoma AIDS-related Kaposi sarcoma |
Neurotransmitter Agents Tranquilizing Agents Sarcoma, Kaposi Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Valproic Acid Recurrence Herpesviridae Infections |
Kaposi Sarcoma Virus Diseases Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas Sarcoma DNA Virus Infections Anticonvulsants |
Neurotransmitter Agents Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Sarcoma, Kaposi Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Valproic Acid Pharmacologic Actions |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue GABA Agents DNA Virus Infections Central Nervous System Agents Anticonvulsants |