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

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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.