The North American Brain Tumor Consortium (NABTC) was formed in 1993 and has continuously conducted early phase clinical trials for patients with malignant brain tumors. The Central Operations Office/Coordinating Center for the NABTC is at the University of California San Francisco (UCSF) under the Group Leadership of Michael Prados, MD. The UCSF Central Operations Office/Coordinating Center for this renewal grant application will continue to coordinate the scientific and administrative activities of the Participating Member Institutions and Pharmacokinetics Center of the NABTC. The NABTC will be composed of 7 full Member Institutions from across the United States, a non-funded Member Institution at the NCI/NINDS Neuro-Oncology Branch, and 1 Pharmacokinetics Center at the University of Texas San Antonio. The NABTC will coordinate its efforts with the Cancer Therapy Evaluations Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Therapy to conduct novel therapies in this patient population. The Central Operations Office/Coordinating Center will provide administrative management, coordination of protocol development and submissions, study conduct, quality control, protocol performance monitoring, statistical analysis, adherence to requirements regarding NCI drug accountability, FDA, OHRP and HHS regulations, and protocol and institutional performance reporting. As Group Leader, Dr. Prados will oversee the scientific, clinical and administrative activities of the NABTC, with the assistance of CTEP, in order to achieve the NABTC goals. Data Management for the NABTC will continue to be supported by a subcontract with the MD Anderson Cancer Center Data Management Center. The goal of the NABTC Central Operations Office/Coordinating Center will be to assure high quality research during the conduct of ongoing and new novel clinical trials and to perform ancillary laboratory investigations of aspects of CNS tumor biology with potential clinical implications. In this renewal application, the NABTC will also plan to interact with the other funded adult (NABTT) and pediatric (PBTC) brain tumor consortia, the Mouse Models of Human Cancer Consortium, the recently funded Brain Tumor SPORE institutions (UCSF and University of Alabama), and the intramural Neuro-Oncology Branch at the NIH/NCI. The NABTC, with the assistance of the Central Operations Office/Coordinating Center, its Member Institutions and Pharmacokinetics Center, has worked well together over the last 9 years, accruing nearly 1000 patients to phase I and early phase II studies in the last 5 years, and seeks to further enhance this effort in the next 5 years. The NABTC will treat patients using novel therapeutic agents with the ultimate goal to increase quality, and hopefully, overall survival in this patient population.
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