NABTT-Consortium Therapeutic Studies of CNS Malignancies

描述（由申请人提供）：本提案的主要目的是改善成人原发性脑肿瘤的治疗效果。次要目标是分享临床和实验室数据和人类脑肿瘤标本，以开展有关原发性脑肿瘤的基础生物学，新疗法的神经药理学，以及改善原发性脑肿瘤成人的护理和生活质量的研究。通过“脑肿瘤治疗新方法（NABTT）中枢神经系统联盟”的持续努力，这些目标将通过使用有前景的新药、生物方法、给药途径和治疗原发性脑肿瘤的试验设计进行I期和II期临床试验来实现。该联盟结合并集中了十家优秀医疗机构（克利夫兰诊所、埃默里大学、亨利福特医院、约翰霍普金斯大学、马萨诸塞州总医院、莫菲特癌症中心、国家癌症研究所校内神经肿瘤项目、阿拉巴马大学伯明翰分校、宾夕法尼亚大学和维克森林大学）的经验、资源和能力，以研究原发性脑肿瘤。这些参与机构拥有(1)大量的成人原发性脑肿瘤患者，(2)照顾这些患者的专家多学科临床团队，(3)广泛的临床、实验室和影像学资源，(4)许多高质量的、临床相关的、同行评审的临床和实验室脑肿瘤研究项目，(5)全国公认的肿瘤学、药理学、新药开发、临床试验、神经外科、神经病理学(6)在生物统计学、数据管理和多机构研究协调方面的广泛专业知识，以及(7)在临床护理和研究方面的卓越声誉。该联盟通过以下方式增加了这些机构的优势：(1)正式、全面的组织结构；(2)稳定、顺利运作的中央运营办公室；(3)杰出的生物统计学、药理学和相关生物学；(4)强调试验设计、方案开发、质量控制、研究监测和数据分析；(5)与制药公司、计算联盟和其他从事脑肿瘤研究的科学家合作。

DESCRIPTION (provided by applicant): 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.