This proposal is to evaluate promising new therapies for patients with malignant disease in a clinically efficient, regulatory compliant, and scientifically rigorous research environment. Phase I clinical studies of new anti-cancer therapies continue to evolve as basic/ translational research has broadened the targeted opportunities to treat malignant disease. Building upon a strong foundation in the conduct of phase I studies, we have assembled an interactive research team that will use rationally designed clinical trials that will enable expansion and expertise in the molecular/pharmacologic assessment of new drug activity. These trials and assessment methods are designed ultimately to impact on the clinical care of patients diagnosed with cancer. The overall objective of these Phase I studies is to determine the appropriate dose and schedule of experimental agents for further evaluation of efficacy in solid tumor/hematologic malignancies and to characterize the acute and chronic toxicities of these anti-cancer therapies.
Our Specific Aims are 1) To conduct Phase I clinical trials of novel anti-cancer agents (alone or in combination) in a timely manner; 2) To perform detailed pharmacokinetic studies of these new agents and to correlate these observations with relevant clinical/biologically sound endpoints; 3) To implement correlative and pharmacodynamic laboratory evaluations in proof of drug mechanism phase I clinical trials and to explore optimal relationships between parameters of drug exposure and biological effects; and 4) To maintain a clinical trial infrastructure that is current and compliant with regulatory standards that assure quality care to patients enrolled on early phase clinical trials. Interdisciplinary teams with clinical and laboratory expertise in the areas of novel cytotoxics, signal transduction inhibitors, gene expression strategies, and antiangiogenesis are in place to fully evaluate these areas. These teams are collaborative and meet regularly to review clinical data and laboratory correlates. Members of these teams are open to multi-institutional working groups in these areas of strength. As targets change over the ensuing years, these groups will remain flexible to expansion and change to other targets of interest. We expect to enroll 50-60 patients/year in order to conduct and complete 2-3 phase I clinical trials/year via this cooperative agreement.
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