NEW APPROACHES TO BRAIN TUMOR THERAPY-(NABTT)

描述（由申请人提供）：长期目标是通过参与和完成NABTT组织框架内的I/II期临床试验，在约翰霍普金斯大学开发创新方法，以提高中枢神经系统（CNS）原发性恶性肿瘤成人的生存率和生活质量，“脑肿瘤治疗新方法”。自NABTT成立以来，约翰霍普金斯大学一直是NABTT治疗性和非治疗性试验最活跃的地点之一。我们一直是NABTT协议的最大来源。2002年，520名脑肿瘤患者在霍普金斯接受了手术。霍普金斯大学在开展多机构一期和二期临床试验方面有着丰富的经验。肿瘤中心是NCI的一期测试中心，拥有广泛和专业的基础设施，以满足我们在NABTT内的目标。此外，一项针对脑肿瘤的大型研究正在进行，涉及基础实验室、药理学实验室和临床前实验室，目的是为患者开发更有效的治疗方法。大量的实验室由两个多专业小组联合在一起，国家合作药物发现小组“脑肿瘤控制释放聚合物”和脑肿瘤研究的无血管生物学Center@.这些研究成果已经转化为由霍普金斯研究人员进行的7期I、II和III期多机构试验，并导致FDA在23年来首次批准治疗恶性脑肿瘤（Gliadel）。2003年2月，FDA批准格列德尔作为所有恶性神经胶质瘤的初始疗法。此外，Gliasite在霍普金斯大学构思并通过NABTT进行测试后获得了FDA的批准。约翰霍普金斯大学神经肿瘤学项目将利用其丰富的资源和经验为NABTT CNS联盟提供：1)大量成年原发性脑肿瘤患者，2)多学科临床专家团队，3)广泛的临床和实验室资源，4)大量正在进行的高质量，临床相关，同行评审和nih资助的临床和实验室脑肿瘤研究项目，5)全国公认的肿瘤学，神经外科，药理学，新药开发，I期和II期临床试验，神经放射学和神经病理学的专业知识，6)在统计、数据管理、多机构研究协调和脑肿瘤临床试验的创新设计方面拥有广泛的专业知识；7)在临床护理和研究方面享有卓越的声誉。

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.