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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have HIV-related Kaposi's sarcoma. Drugs such as BMS-275291 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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