Valproic Acid in Treating Patients With Kaposi's Sarcoma

Inclusion 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