LIPOSOMAL DOXORUBICIN WITH/WITHOUT BLEOMYCIN & VINCRISTINE FOR AIDS

这是一项开放标签、多中心、比较研究，旨在确定 脂质体阿霉素单独或与 与硫酸长春新碱和硫酸博来霉素联合治疗 治疗晚期艾滋病相关KS。 受试者将入组， 随机接受单独的脂质体阿霉素（20 mg/m2静脉内 每2周一次）或与硫酸长春新碱和博来霉素联合 硫酸盐 它们将根据是否 目前正在接受或未接受G-CSF或GM-CSF治疗，且ACTG肿瘤科 委员会预后变量To vs T1和S 0 vs S1（5）。 受试者将 随后进行体格检查、实验室检查和评估 每两周就有一次不良经历 KS病变的状态将是 在研究药物首次给药前进行评价， 在每隔一个治疗周期之前即刻，以及四周 在最后一个治疗周期结束后。 受试者将接受 研究治疗长达25个周期或累积DOX-SL剂量为500 mg/m2。 根据标准ACTG对肿瘤缓解进行分类 响应标准 治疗可中断长达四周， 发生机会性感染、药物不良反应或 对治疗完全有反应

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.