valproic acid in treating patients with kaposi's sarcoma

Conditions: Sarcoma

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.

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 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

Keywords: recurrent kaposi sarcoma aids-related kaposi sarcoma