A Pilot Trial Of Valproic Acid In Patients With 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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity-related discontinuation rate
28 days
Yes
Richard F. Ambinder, MD, PhD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000349348
NCT00075777
February 2005
February 2008
Name | Location |
---|---|
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 |