This application responds to RFA-CA-08-504 which is intended to continue support for Phase 1 and 2 treatment studies in adults with primary central nervous system cancers and to continue the activities that were funded initially under RFA CA-04-001. This single, consolidated application from the two currently funded separate adult brain tumor consortia: New Approaches to Brain Tumor Therapy (NABTT) and North American Brain Tumor Consortium (NABTC) is designed to maximize clinical trial efficiency and enhance support for translational research. The Adult Brain Tumor Consortium (ABTC) will capitalize on the scientific expertise and experience that has been nurtured during the previous award periods by retaining the majority of the NABTT and NABTC member institutions as well as clinical trial, pharmacology, biostatistics, and neuropathology leadership. The Co-Principal Investigators of the ABTC (Stuart Grossman and Michael Prados) have directed the activities of NABTT and NABTC since their inception in 1994. ABTC will utilize the skills and experience of The NABTT Operations Office (Stuart Grossman and Joy Fisher), the NABTC biostatistician (Kathleen Lamborn), pharmacologists from NABTT and NABTC (Jeff Supko and John Kuhn), and neuro-imaging (Greg Sorensen and Sarah Nelson) and neuropathology (Ken Aldape) experts. Based on predetermined criteria, the ABTC Steering Committee will evaluate potential member sites, dismiss underperforming member sites, and evaluate competitive applications and award funds for pharmacologic, imaging, and correlative biology research. ABTC's committee structure will focus on interactions with the NIH, SPOREs, cooperative groups, institutional translational research, pharmaceutical companies, and novel multidisciplinary approaches. An experienced and international External Advisory Board will provide valuable input to ABTC. This newly consolidated consortium will strive to develop more effective therapies for adult brain tumors by: 1) safely and efficiently introducing novel anticancer agents into the treatment of high grade primary brain tumors through the conduct of Phase 1-2 clinical trials, 2) Proactively seeking collaborations with other NCI-funded clinical trials mechanisms and researchers devoted to finding promising new treatment approaches for adult brain tumors;and 3) Incorporating pharmacokinetic and pharmacodynamic endpoints (including imaging and translational laboratory studies) as appropriate into Phase 1-2 studies.
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