Valproic Acid in Treating Patients With Kaposi's Sarcoma

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Valproic Acid

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