) 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 the most active site with the highest accrual to NABTT therapeutic and non-therapeutic trials. We have been the largest source of NABTT protocols. In 1996, 482 brain tumor patients were treated at Hopkins, of which 112 had high grade gliomas. 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 Vascular Biology of Brain Tumors Research Center . These research efforts have translated into seven 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). The Johns Hopkins Neuro-oncology Program will use its extensive resources and experience to provide the NABTT CNS consortium with: 1) a large n u m b er of adult patients with primary brain tumors, 2) an expert m u ltidisciplinary 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, p h armacology, 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) an exceptional reputation for excellence in clinical care and research.
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