PHASE 2: CCI-779 IN COMBINATION WITH BEVACIZUMAB IN STAGE III OR IV MELANOMA

第 2 期：CCI-779 与贝伐珠单抗联合治疗 III 期或 IV 期黑色素瘤

• 批准号: 8167165
• 负责人: Craig Lee Slingluff
• 金额: $ 4.41万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167165
• 关键词: Biological Markers; CCI-779; Clinical; Computer Retrieval of Information on Scientific Projects Database; Dose; Evaluation; Funding; Goals; Grant; Institution; Investigation; Molecular Target; Monitor; National Cancer Institute; Outcome; Participant; Patients; Phase; Research; Research Personnel; Resources; Safety; Schedule; Series; Site; Source; Specific qualifier value; Staging; United States National Institutes of Health; bevacizumab; design; melanoma

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.

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是贝伐单抗联合CCI-779在III期或IV期黑色素瘤受试者中的多中心II期评价。 最多23名受试者将接受研究治疗。 主要目的是确定贝伐单抗加CCI-779在指定剂量和时间表的治疗是否可以产生足够的抗黑色素瘤临床活性，以保证进一步研究。 治疗将包括26个周期。 每个周期为14天。 CCI-779将在周期1-26的第1天和第8天给药。 贝伐珠单抗将在第1-26周期的第8天给药。 在整个研究期间，将每月监测所有受试者的安全性信息。将使用2阶段设计确定是否应因抗肿瘤活性不足而停止招募。 这项研究是国家癌症研究所赞助的一系列研究之一，参与了分子靶向组合相关（MTC 2）研究计划，以评估与靶向药物治疗患者结局相关的可能生物标志物。