) This application is the University of Texas Southwestern Medical Center (UTSW) proposal to continue participation in Phase I and 11 investigational drug trials in adults with anaplastic gliomas in a multi-institutional consortium, the North American Brain Tumor Consortium (NABTC). The ultimate purpose of this consortium is to identify agents and regimens with sufficient activity to justify definitive Phase III testing. In general, these Phase III trials will be conducted in larger groups in which the NABTC member institutions may participate. With this application, the NABTC is being reorganized and combined with another central nervous system tumor consortium, the NCNSC, to improve efficiency and accelerate accrual. Data management and statistical support for the consortium studies are being transferred to M.D. Anderson Hospital. The Contra Operations Office of the NABTC will continue to be the University of California at San Francisco. In three years, the NABTC has accrued 165 patients to four studies, including one completed protocol (9401) and three protocols nearing completion (9402, 9403, and 9404). Two LOI's for new protocols have been approved (9701 and 9702). The study coordinator for three of these six protocols (9404, 9701, and 9702) is the PI on this application. These and subsequent trials will include pharmacokinetic studies, which will continue to be performed at the University of Texas at San Antonio, and tissue banking for biological studies. Agents or regimens to be tested in subsequent Phase I and 11 trials of the NABTC will be selected during semiannual consortium meetings and will be based on: a) CTEP recommendations and preferences, b) pre-clinical experimental data from p a rticipant consortium institutions, and c) knowledge of the current literature with frequent interchanges about prioritizing potential new regimens. The newly reorganized NABTC estimates accrual of 60-80+ patients per year from the seven institutions that will be enrolling patients. This should allow completion of three to four trials per year, and pharmacokinetic (or other biologic) studies will be conducted on most, if not all, of these trials. UTSW participants in these consortium trials have been and will continue to be a multi-disciplinary team of neuro-oncologists, neurosurgeons, pediatric oncologists, radiation oncologists, and neuropathologists. UTSW is the only brain tumor research center in the north-central Texas region, and approximately 65 patients are enrolled on formal brain tumor protocols annually. With reorganization of the NABTC, we anticipate that a significant percentage of these will be enrolled on NABTC studies, which will be given highest priority within the institution.
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