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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. Identifier: NCT00075777
Recruitment Status : Completed
First Posted : January 13, 2004
Last Update Posted : August 29, 2014
National Cancer Institute (NCI)
The Emmes Company, LLC
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: valproic acid Not Applicable

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Intervention Details:
  • Drug: valproic acid
    250 mg by mouth twice a day
    Other Name: Depakene

Primary Outcome Measures :
  1. Toxicity-related discontinuation rate [ Time Frame: 28 days ]
  2. Lytic induction rate [ Time Frame: 28 days ]
  3. Clinical response rate [ Time Frame: 28 days ]
  4. Accelerated KS progression rate [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed HIV-related Kaposi's sarcoma (KS)

    • Disease involving the skin and/or lymph nodes

      • No symptomatic visceral disease
      • No oral KS as the only site of disease
    • Slowly progressive or stable disease allowed

      • Slow progression defined as fewer than 5 new lesions per month
    • Must have documented HIV infection by positive ELISA, western Blot, or viral load determination
  • CD4 T-cell count > 50/mm^3



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 3 months


  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 750/mm^3
  • Platelet count ≥ 75,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
  • AST and ALT ≤ 3 times ULN
  • Albumin > 2.5 g/dL NOTE: *Elevated total bilirubin (≤ 3.5 mg/dL) secondary to indinavir therapy allowed provided the direct bilirubin is normal


  • Creatinine < 1.5 times ULN


  • No prior myocardial infarction
  • No evidence of cardiac ischemia


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No prior lactic acidosis > 2.0 mmoles/L
  • No prior lipoatrophy or hypercholesterolemia secondary to retroviral treatment
  • No concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within the past 14 days
  • No other concurrent neoplasm requiring cytotoxic therapy


Biologic therapy

  • More than 2 weeks since prior biologic therapy for KS


  • More than 2 weeks since prior chemotherapy for KS
  • No concurrent systemic cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • More than 2 weeks since prior radiotherapy for KS


  • Not specified


  • More than 2 weeks since other prior antineoplastic or local therapy for KS
  • More than 2 weeks since prior investigational therapy for KS
  • More than 60 days since prior local therapy to a KS-marker lesion unless lesion has clearly progressed since therapy
  • More than 1 year since prior valproic acid
  • Concurrent antiretroviral therapy allowed provided regimen has been stable for at least 4 weeks
  • No concurrent zidovudine
  • No other concurrent KS-specific therapy
  • No other concurrent investigational drugs, other than IND-approved antiretroviral agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT00075777

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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
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The Emmes Company, LLC
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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

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Responsible Party: AIDS Malignancy Consortium Identifier: NCT00075777    
Other Study ID Numbers: AMC-038
U01CA070019 ( U.S. NIH Grant/Contract )
CDR0000349348 ( Other Identifier: NCI )
First Posted: January 13, 2004    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by AIDS Malignancy Consortium:
recurrent Kaposi sarcoma
AIDS-related Kaposi sarcoma
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs