Valproic Acid in Treating 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma|
- Toxicity-related discontinuation rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Lytic induction rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Clinical response rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Accelerated KS progression rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Drug: valproic acid
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075777
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Veterans Affairs Medical Center - San Diego|
|San Diego, California, United States, 92161|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0324|
|United States, Georgia|
|Georgia Cancer Center for Excellence at Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|Joan Karnell Cancer Center at Pennsylvania Hospital|
|Philadelphia, Pennsylvania, United States, 19106|
|United States, Washington|
|Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center|
|Seattle, Washington, United States, 98111|
|Study Chair:||Richard F. Ambinder, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|
|Study Chair:||Mary Jo Lechowicz, MD||Georgia Cancer Center for Excellence at Grady Memorial Hospital|