NABTT2111 - BMS-247550

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项临床试验的剂量发现(持续重新评估法)阶段的目标是：1)确定BMS-247550在接受(A组)或不接受(B组)已知由P450肝酶复合体代谢的抗惊厥药物的复发恶性胶质瘤成人患者中的最大耐受量。2)通过测定BMS-247550来描述该给药途径的药代动力学，并确定肝酶诱导剂(如抗惊厥药)对药代动力学的影响。安全性/有效性最大耐受量阶段的目标是：1)确定复发性脑胶质瘤患者在最大耐受量阶段应用BMS-247550的有效率。2)描述该方案在成人复发性恶性胶质瘤患者中的毒性。次要目的a)确定成人复发性恶性胶质瘤患者的6个月无进展生存期、无进展生存期和与该治疗相关的生存期。BMS-247550是百时美施贵宝生产的天然产物埃博西酮B的甲基半合成类似物。目的：在12例晚期卵巢癌患者(所有乳腺癌、宫颈癌和卵巢癌患者都曾接受紫杉烷治疗)中，CA125降低50%的乳腺癌和宫颈癌患者已观察到疗效。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objectives of the Dose Finding (Continual Reassessment Method (CRM)) phase of this clinical trial are 1) To determine the maximum tolerated dose of BMS-247550 when administered to adults with recurrent malignant gliomas, receiving (Group A) or not receiving (Group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. 2) To describe the pharmacokinetics of this route of administration, measuring BMS-247550, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants , on the pharmacokinetics . The objectives for the Safety/Efficacy at Maximum Tolerated Dose (MTD) phase are 1) To determine the response rate of adult patients with recurrent glioma to BMS-247550 administered at the MTD. 2) To describe the toxicity associated with this regimen in adult patients with recurrent malignant gliomas. Secondary Objective a) To determine the percent of patients with 6 month progression free survival, duration of progression free survival and survival associated with this therapy in adult patients with recurrent malignant gliomas. BMS-247550 is a methyl, semi-synthetic analog of the natural product epothilone B produced by Bristol-Myers Squibb. Objective responses have been observed in patients with breast and cervical cancer; with > 50% reduction in CA125 in two of 12 patients with advanced ovarian cancer (all breast, cervical and ovary cancer patients had prior taxane therapy).