The primary objective of this proposal is to improve the therapeutic outcome for adults with primary brain tumors. The secondary objective is to share clinical and laboratory data and human brain tumor specimens to conduct research pertaining to the basic biology of primary brain tumors, the neuro-pharmacology of novel therapies, and improving the care and quality of life of adults with primary brain tumors. These objectives will be accomplished by conducting Phase I and II clinical trials using promising new agents, biologic approaches, routes of administration, and trial designs for the treatment of primary brain tumors through the continued efforts of the """"""""New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium."""""""" This consortium combines and focuses the experience, resources, and capabilities of ten outstanding medical institutions (Cleveland Clinic, Emory University, Henry Ford Hospital, Johns Hopkins University, Massachusetts General Hospital, Moffitt Cancer Center, National Cancer Institute Intramural Neuro-Oncology Program, the University of Alabama at Birmingham, University of Pennsylvania, and Wake Forest University) to bear on primary brain tumors. These participating institutions have (1) a large number of adults with primary brain tumors, (2) expert multidisciplinary clinical teams caring for these patients, (3) extensive clinical, laboratory, and imaging resources, (4) many high quality, clinically relevant, peer-reviewed, clinical and laboratory brain tumor research projects, (5) nationally recognized expertise in oncology, pharmacology, new drug development, clinical trials, neurosurgery, and neuropathology (6) extensive expertise in biostatistics, data management, and the coordination of multi-institutional studies, and (7) exceptional reputations for excellence in clinical care and research. The consortium adds to these institutional strengths with: (1) a formal, comprehensive organizational structure, (2) a stable and smoothly functioning Central Operations Office, (3) outstanding biostatistics, pharmacology, and correlative biology, (4) an emphasis on trial design, protocol development, quality control, study monitoring, and data analysis, and (5) collaborations with pharmaceutical companies, a computing consortium, and other scientists conducting brain tumor research.
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