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）：癌症免疫疗法试验网络（CITN）是一个多机构财团，重点介绍了早期临床临床试验，这些试验测试免疫治疗剂和方式治疗癌症患者。 CITN的中央运营和统计中心（COSC）将位于弗雷德·哈钦森癌症研究中心（FHCRC）。 COSC将为全美多达25个会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，统计支持和协议协调。研究目标包括：（1）创建和管理CIST COSC，运行领先的研究人员和机构网络，以确定有前途的药物和通过免疫机制预防和治疗癌症的有前途的药物和策略的安全性，毒性和功效； （2）在资金期间，至少启动15阶段或早期II期试验，这些试验研究了免疫逃避和癌症的基本机制，作为临床试验不可或缺的一部分； （3）将许多肿瘤免疫学实验室整合到CITN中，以便能够使用从患者进行CITN临床试验中获得的标本，以进行免疫调查，生物标志物发育和凭证，并促进对临床试验结果的生物学机制的理解。一个主要的策略是主动从广泛的免疫疗法社区中选择“最佳”同行评审的概念，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和共同研究者结合了多中心临床试验，早期免疫疗法研究以及良好的实验室实践和监测的长期成功历史。 CITN将对最佳实践进行建模，并直接与科学家合作，并管理基于FHCRC的HIV疫苗试验网络，这是一个国际联盟，进行了与HIV相关的免疫治疗临床试验。