NEW APPROACHES TO BRAIN TUMOR THERAPY-(NABTT)

脑肿瘤治疗新方法 - (NABTT)

• 批准号: 6895463
• 负责人: HENRY BREM
• 金额: $ 11.72万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-18 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6895463
• 关键词: antineoplastics; brain disorder chemotherapy; cancer registry /resource; central nervous system neoplasms; clinical research; clinical trial phase I; cooperative study; drug screening /evaluation; glioma; human mortality; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer pharmacology; neoplasm /cancer radiation therapy; neoplasm /cancer surgery; neuropharmacology; neurosurgery; quality of life; statistics /biometry; tissue resource /registry

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.

描述（由申请人提供）：长期目标是在约翰霍普金斯大学开发创新方法，通过参与并完成NABTT组织框架内的I/II期临床试验，“脑肿瘤治疗的新方法”，改善患有中枢神经系统（CNS）原发性恶性肿瘤的成人的生存率和生活质量。自NABTT创建以来，约翰·霍普金斯大学一直是NABTT治疗和非治疗试验累积率最高的最活跃研究中心之一。我们一直是NABTT协议的最大来源。2002年，520名脑瘤患者在霍普金斯接受了手术。霍普金斯在开展多机构I期和II期试验方面拥有丰富的经验。肿瘤中心是NCI的I期测试中心，拥有广泛而专业的基础设施，以满足我们在NABTT内的目标。此外，一项关于脑肿瘤的大型研究正在进行中，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系在一起，即国家合作药物发现小组“脑肿瘤控释聚合物”和脑肿瘤无血管生物学研究中心。这些研究工作已经转化为7个I、II和III期多机构试验，由霍普金斯研究人员进行，并导致FDA 23年来首次批准用于治疗恶性脑肿瘤（Gliadel）。2003年2月，FDA扩大了Gliadel作为所有恶性胶质瘤初始治疗的批准范围。此外，Gliasite在霍普金斯构思并通过NABTT测试后获得FDA批准。约翰霍普金斯神经肿瘤学项目将利用其广泛的资源和经验，为NABTT CNS联盟提供：1）大量患有原发性脑肿瘤的成年患者，2）专家多学科临床团队，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）在肿瘤学，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方面的国家认可的专业知识，6）在统计学，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的广泛专业知识和7）在临床护理和研究方面的卓越声誉。