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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
250 mg by mouth twice a day
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
Toxicity-related discontinuation rate
Time frame: 28 days
Lytic induction rate
Time frame: 28 days
Clinical response rate
Time frame: 28 days
Accelerated KS progression rate
Time frame: 28 days
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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The Bronx, New York, United States
...and 3 more locations