Phase I Trials of Anti-Cancer Agents

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DESCRIPTION (provided by applicant): Phase I studies play a critical role in the development of new cancer therapies. These trials are the initial interface between basic and clinical research for "first in human" studies. Successful therapeutic research embodies an iterative process between the clinic and the laboratory during this critical period of initial development. Whereas in the past, phase 1 trials focused strictly upon defining the toxicity and pharmacokinetics of new agents, the current emphasis requires that more information is efficiently procured without compromising the analysis of safe and effective administration. This mandate requires real-time procurement of pharmacokinetics, pharmacodynamics, and pharmacogenomics as well as meticulous clinical assessment. In this application, both clinical and basic science investigators of The Ohio State University Comprehensive Cancer Center (OSUCCC) join in a collaborative approach to conduct phase I trials of new cancer therapeutic agents and regimens. Investigators will cooperate closely with the National Cancer Institute in developing correlative studies to evaluate clinical outcomes in the context of basic science observations. The present proposal builds upon twenty-six years of experience and the scientific strength of the OSUCCC in conducting clinical trials with pertinent biologic measurements. Trials will target agents and strategies with which our faculty has prior preclinical experience and/or cellular and molecular networks under study in their laboratories. The Experimental Therapeutics Program at OSUCCC has expertise in signal transduction pathways, angiogenesis, cell cycle control, selective induction of tumor cell apoptosis, monoclonal antibodies, molecular genetics, histone protein modification, DNA methylation and other basic targeted therapeutic strategies. The Ohio State University represents one of the most comprehensive biomedical research campuses in the world dedicated to interdisciplinary research. Respective scientists associated with experimental therapy of cancer form a critical mass within the Colleges of Medicine and Public Health, Pharmacy, Biological Sciences, Mathematical and Physical Sciences, Veterinary Medicine, Engineering, Dentistry, and Nursing. The ultimate goal is to conduct expedient (yet thorough) dose-finding trials in man with the intention of providing safe and effective new therapy to benefit patients with malignant diseases.