NEW APPROACHES TO BRAIN TUMOR THERAPY-(NABTT)

脑肿瘤治疗新方法 - (NABTT)

• 批准号: 7336578
• 负责人: HENRY BREM
• 金额: $ 3.22万
• 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/7336578
• 关键词: Active Sites; Adult; Alabama; Biology; Brain; Brain Neoplasms; Cancer Center; Caring; Clinic; Clinical; Clinical Research; Clinical Trials; Community Clinical Oncology Program; Development; Drug Discovery Groups; Employee Strikes; Funding; General Hospitals; Gliadel; Goals; Health Sciences; Institution; Laboratories; Malignant Glioma; Malignant Neoplasms; Malignant neoplasm of brain; Malignant neoplasm of central nervous system; Massachusetts; Medical; Monitor; Neuraxis; New Agents; Numbers; Operative Surgical Procedures; Outcome; Patient Care; Patients; Peer Review; Pennsylvania; Pharmacology; Phase; Phase I/II Trial; Polymers; Process; Protocols documentation; Quality of life; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Route; Running; Source; Testing; Therapeutic; Therapy Clinical Trials; Translating; United States Food and Drug Administration; Universities; base; clinically relevant; controlled release; data management; design; driving force; drug development; experience; forest; improved; innovation; multidisciplinary; neuro-oncology; neuropathology; neurosurgery; novel strategies; oncology; pre-clinical; programs; protocol development; research clinical testing; size; statistics

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 1/11clinical 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 11 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.

长期目标是在约翰霍普金斯大学开发创新方法，以提高 生活的成年人原发性恶性肿瘤的中枢神经系统（CNS），通过参与和完成 NABTT组织框架内的1/11期临床试验，“脑肿瘤的新方法” 心理治疗”。自NABTT成立以来，约翰霍普金斯一直是最活跃的研究中心之一，累积费用最高 NABTT治疗性和非治疗性试验。我们一直是NABTT协议的最大来源。2002年， 脑肿瘤患者在霍普金斯接受手术。霍普金斯在开展多项 机构I期和II期试验。肿瘤中心是NCI的I期测试中心， 和专业的基础设施，以实现我们在NABTT的目标。此外，一项针对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，目标是开发更多 有效治疗患者。大量的实验室由两个多专业小组联系在一起， 国家合作药物发现小组“用于脑肿瘤的控释聚合物”和无血管 脑肿瘤生物学研究中心。这些研究工作已转化为7个阶段I，II和III多- 由霍普金斯研究人员进行的机构试验导致FDA在23年内首次批准治疗 恶性脑肿瘤（Gliadel）。2003年2月，FDA扩大了Gliadel作为初始治疗的批准范围 所有恶性神经胶质瘤。此外，Gliasite在霍普金斯构思和测试后获得FDA批准 通过NABT。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）惊人的数量正在进行的高 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） 国家认可的肿瘤学、神经外科、药理学、新药开发、I期和11期专业知识 临床试验、神经放射学和神经病理学，6）在统计学、数据管理、协调 多机构研究，脑肿瘤临床试验的创新设计，以及7） 卓越的临床护理和研究。