Sarcoma Clinical Trial
Official title:
A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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