Roswell Park Cancer Institute (RPCI) has considerable expertise in the development and conduct of pilot, phase I and phase I/I I studies, which are the foundation for the development of novel therapeutic approaches in hematologic and solid tumor malignancies. The Protocol-Specific Research Support (PSRS) Resource supports the conduct of innovative pilot, phase I and phase l/ll clinical investigations developed by RPCI investigators and emanating from the CCSG Programs. The continued vitality and translational potential of CCSG Programs relies critically on this support for early phase studies. With the recent recruitment of a number of new investigators to the CCSG Programs and RPCI, it is anticipated that accrual will increase substantially over the next several years. Alex A. Adjei, MD, PhD has been recruited to RPCI and now serves as director of this Resource. The primary responsibilities of the clinical research coordinators in this Resource are the implementation, conduct, oversight, collection and quality control of data for phase I and pilot studies. Dr. Adjei oversees the prioritization for the use of PSRS resources in his capacity as Associate Director for Clinical Research and Director of Clinical Shared Resources. In order to be eligible for PSRS, the study must be led by an RPCI investigator or have resulted from clinical or preclinical studies performed by an RPCI investigator with an RPCI faculty member as a co-investigator. Over the last grant period, a number of studies have been activated based on basic research findings of CCSG investigators in vitamin D, selenium and the NY-ESO-1 antigen, among others. Examples include a pilot study of low and high dose vitamin D3 with pharmacokinetic and pharmacodynamic correlates in resected colon cancer (Fakih, Trump and Johnson), calcitriol combined with gefitinib, selenomethionine and irinotecan (Fakih) and NY-ESO-1 antigen vaccination for ovarian cancer (Odunsi). A new photosensitizer for photodynamic therapy, HPPH has been tested in a phase I study (Henderson). Future development continues. A study of surgery combined with intra-operative photodynamic therapy in head and neck cancers is ongoing (Rigual). Other studies include a pilot study of the effect of low glycemic index diet on breast density (McCann), Hsp-based vaccines (Subjeck, Kane, Yang), and novel diagnostic/prognostic marker evaluations - FRA12/SMRT (Coignet, Trump). All these projects were developed with, have led to, or are future components of peer-reviewed funding support.
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