Valproic Acid in Treating Patients With Kaposi's Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00075777|
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : August 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: valproic acid||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||February 2008|
U.S. FDA Resources
Drug: valproic acid
- Toxicity-related discontinuation rate [ Time Frame: 28 days ]
- Lytic induction rate [ Time Frame: 28 days ]
- Clinical response rate [ Time Frame: 28 days ]
- Accelerated KS progression rate [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|
|Study Chair:||Mary Jo Lechowicz, MD||Georgia Cancer Center for Excellence at Grady Memorial Hospital|