Therapeutic Studies of Primary CNS Malignancies-NABTT

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DESCRIPTION (provided by applicant): A major thrust of The Brain Tumor Institute (BTI) of the Cleveland Clinic Cancer Center is to advance knowledge of the mechanisms of brain tumor development and growth, through basic science, and to develop new treatment options, by way of engineering collaboration with industry and clinical research. We believe that an ongoing, long-term membership in the NABTT consortium will be our principal means of achieving this goal. The BTI performs more than 600 brain tumor operations per year, of which approximately 150 are on malignant glial neoplasms. Through BTI's Center for Translational Therapeutics, we perform preclinical testing of new, promising brain tumor agents, determining their efficacy and optimum mode of delivery. Additional translational laboratory efforts include adoptive immunotherapy and immune system regulation for brain tumors, convection enhanced delivery of potential therapies, detection of serum tumor markers, and brain image post-processing or multimodality integration and longitudinal autosegmentation and fusion for assessment of treatment efficacy. It is our intention to contribute promising new agents and our expertise in these areas to the NABTT consortium. Since being accepted as a provisional member in NABTT 2 years ago, we have demonstrated our commitment to this organization by participating in or leading NABTT committees, protocol leadership, and having the highest second-year accrual of any active NABTT site, with a third-year projected accrual of about 28 patients. We believe that our yearly contribution of patients to the NABTT consortium will be in the range of 25 to 30 per year. Additional contributions to the Consortium will include 1) new agents with preclinical evidence of efficacy and optimal route of administration, 2) expertise in immunological strategies for brain tumor treatment, 3) new methods of integrating brain imaging and tracking changes over time, 4) expertise in advanced-agent delivery strategies such as convection enhanced delivery, 5) extensive expertise and state-of-art resources in radiotherapy, radiosurgery, surgical navigation, and neuro-imaging, 6) a broad, grant and endowment-supported basic science effort with capability to interface with other NABTT laboratories, 7) a large tumor bank with IRB-approved clinical/pathology/molecular/imaging database correlations, and 8) our expertise in generating and completing Phase I and II clinical trials.