PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

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This offering provides a single-institution proposal for Phase II and III development of anti-cancer agents. The University of Texas M.D. Anderson is comprised of disease-specific clinical cancer teams lead by physicians who have extensive backgrounds in the development of antineoplastic agents. These clinical teams include physicians involved in the treatment of melanomas, sarcomas, breast, gynecological, gastrointestinal, lung, head and neck, genitourinary, and neurological malignancies. Specific physician teams provide expertise in designing clinical trials in bone marrow transplantation and in the treatment of leukemias and lymphomas. To understand the basic science of anti-cancer agents under development at athe institution, laboratory correlative studies teams interact closely with the above clinical investigators. Areas of correlative laboratory investigation include analytical biochemistry, pharmacokinetic/pharmacodynamic studies, immunopharmacology, cellular pharmacology, cellular toxicity/lethality, and polyamine synthesis and inhibition. The clinical cancer and laboratory correlative studies teams are supported by a data management/quality control team which is comprised of a clinical trials support core (clinical trials administration, data management and quality assurance, data management support, and scientific=c review committee), biostatistics, and a research pharmacy (clinical materials handling and radiopharmaceuticals). Through the collaborative interaction of the above three teams, new anticancer agents which have undergone Phase I testing are further developed. The proposal provides a mechanism to determine the spectrum of activity of selected agents across a variety of human cancers, establish the role of new agents (or analogues), alone or in combination, and compare this role with standard therapies. In addition, approaches to Phase II/III development of high dose therapy using colony-stimulating factors, peripheral stem cells, or autologous bone marrow support are provided.