Cancer Immunotherapy Trials Network Central Operations and Statistical Center

描述(由申请人提供)：癌症免疫治疗试验网络(CITN)是一个多机构联盟，专注于测试免疫治疗剂和治疗癌症患者的方式的早期临床试验。CITN的中央运营和统计中心(COSC)将设在弗雷德·哈钦森癌症研究中心(FHCRC)。COSC将为全美最多25个成员机构和肿瘤免疫学实验室提供领导和组织资源，包括基础设施、统计支持和方案协调。研究目标包括：(1)建立和管理CITN COSC，运行一个由领先的研究人员和机构组成的网络，进行早期临床试验，以确定有希望的通过免疫机制预防和治疗癌症的药物和策略的安全性、毒性和有效性；(2)在整个资助期内启动至少15个I期或II期早期试验，作为临床试验的组成部分，调查癌症免疫逃避和耐药的基本机制；以及(3)将多个肿瘤免疫学实验室整合到CITN中，以便使用从CITN临床试验患者那里获得的样本进行免疫监测、生物标记物开发和认证，并促进对临床试验结果背后的生物学机制的了解。一项主要战略将是积极主动地从广泛的免疫治疗社区中选择“最好的”同行评议的概念，并利用CITN指导委员会的集体经验来构建“理想的”方案，包括使用难以获得优先次序的免疫治疗药物。PI和合作调查员结合了多中心临床试验实施、早期免疫治疗研究以及良好的实验室实践和监测的长期成功历史。CITN将模拟最佳实践，并直接与基于FHCRC的艾滋病毒疫苗试验网络的科学家和管理层合作，该网络是一个进行艾滋病毒相关免疫治疗临床试验的国际财团。

DESCRIPTION (provided by applicant): The Cancer Immunotherapy Trials Network (CITN), a multi-institutional consortium, focuses on early-phase clinical trials that test immunotherapeutic agents and modalities to treat patients with cancer. The Central Operations and Statistical Center (COSC) of the CITN will be based at the Fred Hutchinson Cancer Research Center (FHCRC). The COSC will provide leadership and organizational resources, including infrastructure, statistical support, and protocol coordination, for up to 25 member institutions and tumor immunology laboratories throughout the US. The research goals include: (1) creating and managing the CITN COSC to run a network of leading investigators and institutions to conduct early-phase clinical trials to determine the safety, toxicity, and efficacy of promising agents and strategies to prevent and treat cancer by immune mechanisms; (2) initiating at least 15 phase I or early phase II trials over the course of the funding period that investigate the basic mechanisms of immune evasion and resistance of cancers as an integral part of clinical trials; and (3) integrating a number of tumor immunology laboratories into the CITN to enable the use of specimens obtained from patients on CITN clinical trials for immunomonitoring, biomarker development and credentialing, and facilitating an understanding of the biological mechanisms that underlie the results of the clinical trials. A major strategy will be to proactively choose the "best" peer-reviewed concepts from the broad immunotherapy community and use the collective experience of the CITN Steering Committee to construct "ideal" protocols including use of hard-to-get prioritized immunotherapy agents. The PI and Co-Investigators combine long successful histories of multicenter clinical trial conduct, early-phase immunotherapy research, and good laboratory practice and monitoring. The CITN will model the best practices and collaborate directly with scientists and management of the FHCRC-based HIV Vaccine Trials Network, an international consortium that conducts HIV-related immunotherapeutic clinical trials.