CLINICAL TRIAL: PHASE 2: CCI-779 IN COMBINATION WITH BEVACIZUMAB IN STAGE III OR

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是对患有III或IV期黑色素瘤的参与者进行的贝伐单抗加CCI-779的多部位II期评估。多达23名参与者将接受研究治疗。主要目标是确定贝伐单抗加CCI-779在指定剂量和时间表下的治疗是否可以产生足够的临床活性来对抗黑色素瘤，值得进一步研究。 治疗将包括26个周期。每个周期为14天。CCI-779将在第1-26周期的第1天和第8天给药。贝伐单抗将在第1-26周期的第8天给药。在整个研究过程中，将每月监测所有参与者的安全信息。将使用两阶段设计来确定是否应因抗肿瘤活性不足而停止应计。 这项研究是美国国家癌症研究所赞助的一系列研究之一，该研究参与了分子靶向联合相关(MTC2)研究计划，以评估与靶向药物治疗的患者结果相关的可能的生物标记物。

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. This is a multi site phase II evaluation of bevacizumab plus CCI-779, in participants with stage III or IV melanoma. Up to 23 participants will receive study treatment. The primary goal is to ascertain whether treatment with bevacizumab plus CCI-779 at the specified doses and schedule can produce sufficient clinical activity against melanoma to warrant further investigation. Treatment will consist of 26 cycles. Each cycle is 14 days. CCI-779 will be administered on days 1 and 8 of cycles 1-26. Bevacizumab will be administered on day 8 of cycles 1-26. Safety information will be monitored monthly on all participants throughout the study. A 2-staged design will be used to determine if accrual should be halted due to insufficient antitumor activity. This study is one of a series of National Cancer Institute sponsored studies participating in the Molecular Targeted Combinations Correlative (MTC2) Study Initiative to evaluate possible biomarkers that correlate with patient outcomes to treatment with targeted agents.