Dana-Farber/Harvard Cancer Center ET-CTN with Phase I Emphasis

描述(由申请人提供)：NCI指定的Dana-Farber/哈佛癌症中心(DF/HCC)。包括Dana-Farber癌症研究所(DFCI)/布里格姆妇女医院(BWH)、马萨诸塞州综合医院(MGH)和贝丝以色列女执事医疗中心(BIDMC)，以及在这些地点进行的临床试验的所有方面的监督职能。作为牵头学术组织(LAO)的DF/HCC的这份UM1合作协议申请的总体目标是提供临床和科学专业知识以及患者资源，以参与NCI实验治疗-临床试验网络(ET-CTN)。DF/HCC翻译药理学和早期治疗试验(TPETT)计划在1993年开始实施的.NCI/CTEP第一阶段U01协议的支持下，协调了DF/HCC的早期药物开发工作。在目前的资助期间(2008年2月1日至今)，DF/HCC TPETT计划的成员参与了48项由CTEP赞助的试验，总体收益为470名患者(85人/年)。DF/HCC还与其他U01站点，如MSKCC、MDACC和Karmanos癌症研究所合作，进行CTEP试验。DF/HCC ET-CTN网站将由一个领导和指导委员会组成，该委员会将监督监管、药代动力学、基因组、基于病理学、生物统计学和职业发展的组成部分。DF/HCC将致力于与NCI和其他ET-CTN网站组成特定于研究试剂的跨网络项目小组，以确定药物开发计划，并对CTEP赞助的药物进行早期治疗试验。DF/HCC ET-CTN在药代动力学、药效学、癌症生物学、生物标记物分析开发、成像和分子特征方面的专业知识将以基于团队的方法与其他网站共享。还将强调对初级调查人员进行实验治疗学方面的辅导培训。 相关性：这项工作对公众健康的重要性是通过需要改善对现有治疗无效的大量(晚期)癌症患者的治疗选择来实现的，这些患者是新的研究试剂的候选者。在这份UM1合作协议中提出的研究重点是加速这些患者获得新的分子靶向治疗策略。

DESCRIPTION (provided by applicant): The NCI-designated Dana-Farber/Harvard Cancer Center (DF/HCC).includes the Dana-Farber Cancer Institute (DFCI)/Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and the Beth Israel Deaconess Medical Center (BIDMC) and functions in overseeing all aspects of clinical trials performed at these sites. The overall objective of this UM1 Cooperative Agreement application from the DF/HCC, which serves as the Lead Academic Organization (LAO), is to provide the clinical and scientific expertise and patient resources to participate in the integrated NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN). The DF/HCC Translational Pharmacology and Early Therapeutic Trials (TPETT) Program has coordinated early phase drug development efforts at DF/HCC with support under an.NCI/CTEP Phase I U01 Agreement in place since 1993. During the current funding period (2/1/2008-present), members of the DF/HCC TPETT Program have participated in the conduct of 48 CTEP-sponsored trials with an overall accrual of 470 patients (85/year). The DF/HCC has also collaborated with other U01 sites, such as MSKCC, MDACC and Karmanos Cancer Institute, in the performance of CTEP trials. The DF/HCC ET-CTN site will consist of a Leadership and Steering Committee that will oversee regulatory, pharmacokinetic, genomic, pathology-based, biostatistical, and career development components. DF/HCC will be committed to the formation of investigational agent-specific trans-network Project Teams with the NCI and other ET-CTN sites to define drug development plans and conduct early phase therapeutic trials of CTEP-sponsored agents. Expertise of the DF/HCC ET-CTN in pharmacokinetics, pharmacodynamics, cancer biology, biomarker assay development, imaging and molecular characterizations will be shared with other sites in team-based approaches. Emphasis will also be placed on mentored training of junior investigators in experimental therapeutics. RELEVANCE: The importance of this work to (the) public health is realized by the need for improved treatment options for the substantial number of patients with (advanced) cancer unresponsive to existing treatments, who are candidates for new investigational agents. The research proposed in this UM1 Cooperative Agreement is focused on accelerating access to new molecularly-targeted treatment strategies for these patients.