BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed Kaposi's sarcoma (KS) with serologically documented HIV infection
• •No symptomatic visceral KS requiring cytotoxic therapy unless refractory to or intolerant of all currently approved agents for visceral KS
• •At least 5 measurable lesions
• •* No prior local therapy to any indicator lesion unless clear progression has taken place since treatment
• •PATIENT CHARACTERISTICS:
• •Age:
• •16 and over
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •Absolute neutrophil count at least 750/mm3
• •Platelet count at least 75,000/mm3
• •Hemoglobin at least 8 g/dL
• •Hepatic:
• •Bilirubin no greater than 1.0 times upper limit of normal (ULN) (no greater than 3.5 mg/dL if secondary to indinavir therapy provided direct bilirubin normal)
• •AST and ALT no greater than 3 times ULN
• •Renal:
• •Creatinine no greater than 1.5 times ULN OR
• •Creatinine clearance greater than 60 mL/min
• •Other:
• •No acute, active opportunistic infection within the past 14 days except oral thrush or genital herpes
• •No other serious medical illness within the past 14 days
• •No other malignancy requiring cytotoxic therapy
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 3 weeks since prior biologic therapy for KS and recovered
• •Chemotherapy:
• •At least 3 weeks since prior chemotherapy for KS and recovered
• •No concurrent systemic chemotherapy for KS
• •Endocrine therapy:
• •No concurrent corticosteroids except replacement doses
• •Radiotherapy:
• •At least 3 weeks since prior radiotherapy for KS and recovered
• •Other:
• •All antiretroviral therapy must be at a stable dose for at least the past 4 weeks and during treatment
• •At least 3 weeks since prior local therapy for KS and recovered
• •At least 3 weeks since prior investigational therapy for KS and recovered
• •At least 14 days since prior acute treatment of infections other than thrush and genital herpes
• •Recovered from toxic effects of any other prior KS treatment
• •No other concurrent investigational drugs except investigational new drug (IND)-available antiretroviral agents
• •No other concurrent KS-specific treatment