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Valproic Acid in Treating Patients With Kaposi's Sarcoma
This study has been completed.
First Received: January 9, 2004   Last Updated: August 12, 2008   History of Changes
Sponsors and Collaborators: AIDS Associated Malignancies Clinical Trials Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075777
  Purpose

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 Intervention
Sarcoma
Drug: valproic acid

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: February 2005
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

  • 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

Renal

  • Creatinine < 1.5 times ULN

Cardiovascular

  • No prior myocardial infarction
  • No evidence of cardiac ischemia

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior biologic therapy for KS

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 2 weeks since prior radiotherapy for KS

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075777

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0324
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
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 Associated Malignancies Clinical Trials Consortium
Investigators
Investigator: 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
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000349348, AMC-038
Study First Received: January 9, 2004
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00075777     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent Kaposi sarcoma
AIDS-related Kaposi sarcoma

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Sarcoma, Kaposi
Psychotropic Drugs
Central Nervous System Depressants
Antimanic Agents
Valproic Acid
Recurrence
Herpesviridae Infections
Kaposi Sarcoma
Virus Diseases
Neoplasms, Connective and Soft Tissue
Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Sarcoma
DNA Virus Infections
Anticonvulsants

Additional relevant MeSH terms:
Neurotransmitter Agents
Neoplasms by Histologic Type
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sarcoma, Kaposi
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Vascular Tissue
GABA Agents
DNA Virus Infections
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 04, 2009