LIPOSOMAL DOXORUBICIN WITH/WITHOUT BLEOMYCIN & VINCRISTINE FOR AIDS

这是一项开放标签的多中心比较研究，旨在确定 阿霉素脂质体单独或联合应用的长期安全性和有效性 硫酸长春新碱和硫酸博莱霉素联合治疗 晚期艾滋病相关KS的治疗。科目将被录取，并 随机接受阿霉素脂质体单独注射(20 mg/m2静脉注射) 每2周一次)或联合硫酸长春新碱和博莱霉素 硫酸盐。他们将在随机化时根据他们是否 目前正在或没有接受G-CSF或GM-CSF和ACTG肿瘤科的治疗 委员会预测变量为VS T1和S0 VS S1(5)。研究对象将 随后进行身体检查、实验室测试和评估 每两周一次的不良经历。KS损伤的状态将为 在第一次服用研究药物之前进行评估， 紧接在每隔一个疗程之前和四周 在最后一个治疗周期结束后。受试者将收到 研究治疗长达25个周期或累积DOX-SL剂量为500 Mg/m2。肿瘤反应将根据标准的ACTG进行分类 响应标准。治疗可能会中断长达四周 发生机会性感染、药物不良反应或 对治疗完全有效。

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.