Early Phase Clinical Research Support

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EARLY-PHASE CLINICAL RESEARCH SUPPORT: PROJECT SUMMARY/ABSTRACT Conducted through the Virginia Commonwealth University Massey Cancer Center (MCC) Clinical Trials Office (CTO), the Early-Phase Clinical Research Support (EPCRS) program provides MCC investigators with a comprehensive, high-quality, integrated platform to facilitate and accelerate the evaluation and development of promising scientific discoveries from the MCC research programs into early-phase clinical trials. Highest priority is given to MCC investigator-initiated trials (IITs) that advance concepts arising from MCC research laboratories into novel proof-of-principle, feasibility, and phase I, single-agent and rationally designed combinations of targeted agents that address the molecular signatures of tumors arising in our patients. Cancer Center Support Grant (CCSG) early-phase funds are used to support the clinical research infrastructure required to promote productive collaborations between basic and translational scientists in the MCC research programs and their MCC clinical research colleagues to translate innovative new approaches to cancer treatment identified through laboratory research into pilot and phase I clinical trials. New concepts for these trials are solicited from research program members and are prioritized by a well-defined and transparent review process overseen by the associate director of clinical research and facilitated by a standing IIT Concept Review Committee composed of senior MCC clinical, translational, and basic scientists. During the current period of support, EPCRS funds have been used to facilitate the opening and conduct of 12 new MCC-led investigator-initiated treatment pilot and phase I trials in solid tumors, hematologic malignancies and radiation oncology. These trials, which required 7 INDs, accrued 168 patients (60%) of the total 281 early-phase accruals. Total early-phase clinical trial local accrual of 281 accounted for 33% of the total MCC treatment trial accrual of 855 patients. MCC IITs have resulted in the definition of maximum tolerated doses for drugs and drug combinations and have identified cancers particularly sensitive to novel therapies suitable for phase II trials. The prioritization process in place is used to pursue a pipeline of additional innovative pilot and phase I trials, of which 6 are currently poised for initiation, with another 7 under development. Support from EPCRS funds focuses on trials addressing the unmet needs of the patient population in the catchment area served by MCC and support the mission of the NIH/NCI by providing access to early-phase clinical trials to patients within the largely underserved and minority populations in the MCC catchment area.