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

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