The Lombardi Comprehensive Cancer Center (LCCC) supports high priority, innovative, pilot or phase I institutional trials focusing on initial early phase testing of a candidate agent or device for the diagnosis, prevention, detection or treatment of cancer. Potential institutional trials arise from LCCC's Research Programs and are developed within disease-focused groups. Letters-of-intent (LOIs) are submitted to LCCC's Protocol Review and Monitoring System (PRMS) Committee for scientific review and prioritization. If the proposed trial is requesting internal funding and is approved by PRMS, the LOI and PRMS reviews are forwarded to the Resource Allocation Subcommittee for Investigator Initiated Trials (RACIIT). RACIIT identifies those trials that are eligible for and merit Early Phase Clinical Research Support (EPCRS) or institutional funding. Once a PRMS-approved LOI is assured of funding, a full protocol can be written and submitted back to PRMS for final approval. If approved by the PRMS and the Institutional Review Board (IRB), previously committed funds are released to provide support for research nursing and/or data management through the Integrated Clinical Research Management Office (ICRMO), and, if designated, for correlative studies. The translation of basic science to the clinic has resulted in the testing of a series of agents that have been developed at LCCC. The strong emphasis on translational research and drug development is reflected in the development and clinical testing of agents targeting growth factors, oncogenic mutations, activated pathways and, more recently, immune checkpoints. These early phase clinical trials are developed on a background of bench-to-bedside-back to bench translational research. Thus, clinical trials can be born out of institutional basic science research (e.g., CDK4/6 inhibition in Gl cancers);out of a combination of clinical research interconnected with basic science research (e.g., PPARy + RXR agonist;Nilotinib + Cetuximab);or clinically driven research that requires strong basic scientific correlates (e.g., rational combination of temsirolimus plus capecitabine;a pilot study of stereotactic radiosurgery with concurrent gemcitabine, a pilot study of tremelimumab in patients with hepatocellular cancer, and studies testing the feasibility of using conditionally reprogrammed cells to predict treatment outcome).
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