Cancer Immunotherapy Trials Network Central Operations and Statistical Center

癌症免疫治疗试验网络中央运营和统计中心

• 批准号: 8034073
• 负责人: Martin Alexander Cheever
• 金额: $ 152.37万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-22 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8034073
• 关键词: Biological; Biological Markers; Clinical Trials; Communities; Conduct Clinical Trials; Credentialing; Development; Disease; Fred Hutchinson Cancer Research Center; Funding; Goals; HIV Vaccine Trials Network; Immune; Immune system; Immunologist; Immunotherapeutic agent; Immunotherapy; Institution; Instruction; International; Laboratories; Leadership; Malignant Neoplasms; Modality; Modeling; Monitor; Patients; Peer Review; Phase; Phase II Clinical Trials; Protocols documentation; Recording of previous events; Research; Research Infrastructure; Research Personnel; Resistance; Resources; Running; Safety; Scientist; Specimen; Testing; Toxic effect; base; cancer immunotherapy; cancer therapy; design; experience; fighting; good laboratory practice; improved; member; operation; prevent; statistical center; tumor immunology

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.

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药物和癌症患者治疗方式的早期临床试验。 CITN 的中央运营和统计中心 (COSC) 将设在 Fred Hutchinson 癌症研究中心 (FHCRC)。 COSC 将为全美多达 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) 创建和管理 CITN COSC，运行一个由领先研究人员和机构组成的网络，开展早期临床试验，以确定有前途的药物的安全性、毒性和有效性以及预防和治疗癌症的策略免疫机制； (2) 在资助期内启动至少15项I期或早期II期试验，研究癌症免疫逃避和耐药的基本机制，作为临床试验的组成部分； (3) 将一些肿瘤免疫学实验室整合到 CITN 中，以便能够使用从 CITN 临床试验中获得的患者标本进行免疫监测、生物标志物开发和认证，并促进对临床结果背后的生物学机制的理解试验。一个主要策略是主动从广泛的免疫治疗界选择“最佳”同行评审概念，并利用 CITN 指导委员会的集体经验来构建“理想”方案，包括使用难以获得的优先免疫治疗药物。 PI 和联合研究人员结合了长期成功的多中心临床试验历史、早期免疫治疗研究以及良好的实验室实践和监测。 CITN 将模仿最佳实践，并直接与基于 FHCRC 的 HIV 疫苗试验网络的科学家和管理层合作，该网络是一个进行 HIV 相关免疫治疗临床试验的国际联盟。