NEW APPROACHES TO BRAIN TUMOR THERAPY-(NABTT)

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DESCRIPTION (provided by applicant): The long-term objective is to develop innovative approaches at Johns Hopkins to improve the survival and quality of life of adults with primary malignant tumors of the central nervous system (CNS), by the participation and completion of Phase I/II clinical trials within the organizational framework of NABTT, "New Approaches to Brain Tumor Therapy". Since the creation of NABTT, Johns Hopkins has been one of the most active sites with the highest accrual to NABTT therapeutic and non-therapeutic trials. We have been the largest source of NABTT protocols. In 2002, 520 brain tumor patients underwent surgery at Hopkins. Hopkins has extensive experience in carrying out multi-institutional Phase I and II trials. The Oncology Center, which is a Phase I testing center for the NCI, has an extensive and specialized infrastructure to meet our goals within NABTT. Also, a large research effort in brain tumors is ongoing involving basic laboratories, pharmacology laboratories, and pre-clinical laboratories with the goal of developing more effective treatments for patients. A large number of the laboratories are tied together by two multispecialty groups, the National Cooperative Drug Discovery Group "Controlled Release Polymers for Brain Tumors@ and the AVascular Biology of Brain Tumors Research Center@. These research efforts have translated into 7 Phase I, II, and III multi-institutional trials which were run by Hopkins investigators and led to the FDA's first approval in 23 years for treatment for malignant brain tumors (Gliadel). In February 2003 the FDA broadened its approval for Gliadel as initial therapy for all malignant gliomas. Furthermore, Gliasite was approved by the FDA after being conceived at Hopkins and tested through NABTT. The Johns Hopkins Neuro-oncology Program will use its extensive resources and experience to provide the NABTT CNS consortium with: 1) a large number of adult patients with primary brain tumors, 2) an expert multidisciplinary clinical team, 3) extensive clinical and laboratory resources, 4) a striking number of ongoing high quality, clinically relevant, peer-reviewed and NIH-funded clinical and laboratory brain tumor research projects, 5) nationally recognized expertise in oncology, neurosurgery, pharmacology, new drug development, Phase I and II clinical trials, neuroradiology, and neuropathology, 6) extensive expertise in statistics, data management, coordination of multi-institutional studies, and innovative design of brain tumor clinical trials and 7) and exceptional reputation for excellence in clinical care and research.