Valproic Acid in Treating Patients With Kaposi's Sarcoma

NCT00075777 | Completed

• 3 other identifiers: AMC-038U01CA070019CDR0000349348
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

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.

Conditions

Sarcoma

Keywords

recurrent Kaposi sarcoma; AIDS-related Kaposi sarcoma

Outcome Measures

Primary Outcomes (4)

• Toxicity-related discontinuation rate

  28 days

• Lytic induction rate

  28 days

• Clinical response rate

  28 days

• Accelerated KS progression rate

  28 days

Interventions

valproic acid DRUG

250 mg by mouth twice a day

Also known as: Depakene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (13)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0324, United States

Location

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

MeSH Terms

Conditions

Sarcoma; Sarcoma, Kaposi; AIDS-related Kaposi sarcoma

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 13, 2004
• Study Start: February 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: February 1, 2008
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

US (13)