CLINICAL TRIALS CORE

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The goal of the Clinical Trials Core is to provide the expertise and infrastructure to facilitate the completion of all of the patient-based components of research proposed in this Program Project Grant. The core goals will be achieved through accomplishing the following specific aims. 1. Conduct a phase I clinical and pharmacokinetic/pharmacodynamic (PK/PD) trial with HIF1-alpha inhibitor, PX-478, given in combination with radiation therapy for bone metastasesfrom breast cancer ( Project 1, Pi- Garth Powis, D. Phil). 2. Conduct a phase II clinical trial with the new agent imexon for patients with gemcitabine-refractory pancreatic cancer (Project 2, Pi-Robert Dorr, Ph.D). 3. Help integrate new imaging technology that focuses on the measurement of stress response and hypoxia in solid tumors into clinical trials (Project 3, Pi-Robert Gillies, Ph.D.). 4. Design and conduct additional phase I and II clinical trials with other novel agents that interfere with tumor response to stress and hypoxia such as PIS kinase inhibitor PX-886 (Project 1), cyanaziridine analogs (Project 2), and possibly other agents (i.e. mTOR inhibitor) alone or in combination with radiation or chemotherapy drugs. The core C will accomplish these aims by assembling a team of clinical investigators and support research staff at the Arizona Cancer Center that will work closely with project and core leaders on translating novel therapeutic and diagnostic concepts from the bench to the bedside.