The Case Comprehensive Cancer Center requests 3.0 FTE research nurses (1.5 UHC /1.5 CCF) to support innovative, feasibility, and Phase I institutional clinical research protocols with laboratory correlates led by Cancer Center investigators. These trials are of highest priority. The trials listed herein are all investigatorinitiated, in various stages of activation, emanate from inter-programmatic (Programs 5, 6 and 7) collaborations, project a total of accrual of 178 patients, and will be active over the first year of the CCSG renewal. In many instances, the agent was discovered by a Cancer Center investigator who shepherded the preclinical evaluation of the strategy, and reflect integration of translational research via inter-programmatic collaborations. In 2005, we accrued 81 patients to investigator-initiated Phase l/ll trials. The Center has a credible track record in developing new therapeutic agents (drugs and targets described in Programs 2, 3, 5, 6 and 7). This includes: (1) the key invention or description of the new compound or cell type, (2) proceeding to basic science and translational research assessment in preclinical models, and (3) followed by coordination with NCI and/or FDA for toxicity and formulation development. Our Cancer Center has then taken the lead in early phase clinical trials, often by receiving approval through the FDA for initial investigator-initiated IND clinical testing of new drugs and cell-based therapies. It is the Cancer Center orientation that all such trials validate drug effect. The trials will define pharmacodynamic effect(s) coupled with pharmacokinetics of each new agent. For cell and gene-based therapies, we will monitor cellular stem cell recovery and gene expression by in vivo assessment of blood, tissue and tumor samples. Dr. Dowlati will provide oversight of this research activity.
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