This is an open-label, multicenter, comparison study to determine the long-term safety and efficacy of liposomal doxorubicin alone or in combination with vincristine sulfate and bleomycin sulfate in the treatment of advanced AIDS-associated KS. Subjects will be enrolled and randomized to receive liposomal doxorubicin alone (20 mg/m2 intravenously every 2 weeks) or in combination with vincristine sulfate and bleomycin sulfate. They will be stratified at andomization based on whether they are or are not currently receiving G-CSF or GM-CSF and by ACTG Oncology Committee prognostic variables To vs T1 and S0 vs S1 (5). Subjects will be followed with physical examinations, laboratory tests, and evaluation of adverse experiences every two weeks. The status of KS lesions will be evaluated prior to the first administration of study medication, immediately prior to every other cycle of treatment, and four weeks following the end of the last treatment cycle. Subjects will receive study treatment for up to 25 cycles or to a cumulative DOX-SL dose of 500 mg/m2. Tumor response will be classified according to standard ACTG response criteria. Treatment may be interrupted for up to four weeks in subjects who develop opportunistic infections, adverse drug effects or complete response to therapy.
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