) In this application clinical and basic science investigators of The Ohio State University Comprehensive Cancer Center (OSUCCC) join together in a collaborative approach to the conduct of phase I trials of new cancer therapeutic agents and regiments. These investigators will cooperate closely with the Cancer Therapy Evaluation Program of the National Cancer Institute in correlative studies which will evaluate clinical outcomes in the context of basic science observations. The present proposal builds upon the strengths of the OSUCCC in conducting clinical trials with pertinent biologic measurements. Trials conducted under this proposal will emphasize those agents and regimens with which faculty of the OSUCCC have had prior preclinical experience and/or which the applicants identify as impacting on the cellular and molecular network under study in their laboratories. The choice of depsipeptide and halichondrin B for proposed phase I trials reflect those considerations. Thus, correlative studies for those two drugs involve t h e p harmacokinetic and pharmacoanalytic, the apoptosis and signal transduction, the microtubule, and the topoisomerase laboratories in in vivo and in vitro measurements. Other phase I trials will utilize the DNA repair, biological response modifier, immune response, pharmacodynamic, and cancer chemoprevention laboratories as appropriate for the new agent or regiment u n d er investigation. Pharmacokinetics will play a central role in interpretation of clinical and biologic end points. Data management and protocol compliance is enhanced by; computerized data and prospective protocol management system of proven value in the conduct of clinical trials. Patient numbers available for phase I trials coupled with the clinical and basic science collaborative research experience and expertise of this proposal's participants provide an effective means for bringing new cancer agents more rapidly to the cancer patient. Studies done under this proposal not only will advance new therapies from the bench to the bedside, but also will provide insights into cancer biology. These insights in turn will lead to more rational anticancer treatment.
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