Spots Global Cancer Trial Database for Valproic Acid in Treating Patients With Kaposi's Sarcoma
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Trial Identification
Brief Title: Valproic Acid in Treating Patients With Kaposi's Sarcoma
Official Title: A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
Study ID: NCT00075777
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * Determine the safety of valproic acid in patients with Kaposi's sarcoma. * Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients. Secondary * Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients. * Determine clinical response in patients treated with this drug. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, Seattle, Washington, United States
Contact Details
Name: Richard F. Ambinder, MD, PhD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
Name: Mary Jo Lechowicz, MD
Affiliation: Georgia Cancer Center for Excellence at Grady Memorial Hospital
Role: STUDY_CHAIR
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