NCT00075777

Valproic Acid in Treating Patients With Kaposi's Sarcoma

A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	valproic acid	250 mg by mouth twice a day

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-07-01
• Completion: 2008-02-01
• First posted: 2004-01-13
• Last updated: 2014-08-29

Locations

13 sites across 1 country: United States