A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma
- 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.
- 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
Toxicity-related discontinuation rate
Richard F. Ambinder, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Veterans Affairs Medical Center - San Diego||San Diego, California 92161|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Joan Karnell Cancer Center at Pennsylvania Hospital||Philadelphia, Pennsylvania 19107|
|Georgia Cancer Center for Excellence at Grady Memorial Hospital||Atlanta, Georgia 30303|
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center||Seattle, Washington 98111|