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结果。次要目的是分享临床和实验室数据以及人类脑肿瘤标本，以进行与原发性脑肿瘤的基础生物学，新疗法的神经药理学有关的研究，并改善原发性脑肿瘤成人的护理和生活质量。这些目标将通过开展I期和II期临床试验来实现，这些试验使用有前途的新药物、生物学方法、给药途径和试验设计，通过“脑肿瘤治疗新方法（NABTT）CNS联盟”的持续努力来治疗原发性脑肿瘤。“该联盟结合并集中了10个优秀医疗机构（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学项目、伯明翰亚拉巴马大学、宾夕法尼亚大学和维克森林大学）的经验、资源和能力，以承担原发性脑肿瘤。这些参与机构拥有（1）大量患有原发性脑肿瘤的成年人，（2）照顾这些患者的专家多学科临床团队，（3）广泛的临床，实验室和成像资源，（4）许多高质量，临床相关，同行评审，临床和实验室脑肿瘤研究项目，（5）国家认可的肿瘤学，药理学，新药开发，临床试验，神经外科和神经病理学（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。该联合会通过以下方式加强了这些机构的实力：（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）出色的生物统计学、药理学和相关生物学，（4）重视试验设计、方案制定、质量控制、研究监测和数据分析，以及（5）与制药公司的合作，一个计算机联盟和其他从事脑肿瘤研究的科学家。

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.