PEDIATRIC BRAIN TUMOR CLINICAL TRIALS CONSORTIUM

杜克大学脑肿瘤中心的目标是促进一群基础、翻译和临床科学家之间的互动，以改进成人和儿童的原发和转移性脑瘤的诊断和治疗，并培训新的基础、翻译和临床研究人员从事神经肿瘤学工作。杜克大学的脑瘤中心(也被称为神经肿瘤学项目)是杜克大学最古老的器官部位癌症项目之一，它比癌症中心早一代人。杜克大学神经肿瘤学的临床和基础研究始于1937年，由已故的巴恩斯·伍德霍尔医学博士领导，他是杜克大学神经外科的第一教授，也是医学中心的第二任校长。该计划的后续领导人是医学博士盖伊·L·奥多姆、詹姆斯·B·杜克神经外科教授和已故医学博士小斯蒂芬·马哈利博士。自15年前Core Grants启动该计划的正式地位以来，Darell Bigner博士一直领导该计划。神经肿瘤学项目由21名高级教员组成，他们拥有来自国家神经疾病和中风研究所的23项与神经肿瘤学相关的同行评议拨款。在杜克大学对成人和儿童脑瘤患者进行临床试验的能力方面最重大的进步是临床神经肿瘤学的行政重组，以有效地将儿科和成人患者的手术和医疗护理结合起来。这一重要的重组是由杜克综合癌症中心的新任主任O.Michael Colvin医学博士设想并与杜克医院、相关科室主任和校长成功谈判的。首先，1996年，成立了儿科神经肿瘤科，亨利·S·弗里德曼博士担任主任，并增加了两名儿科神经肿瘤科教员。然后，弗里德曼博士被任命为内科和外科的医生，他和神经外科主任艾伦·弗里德曼博士被任命为杜克大学临床神经肿瘤科的联席主任。办公室、数据管理人员、医生延伸员以及内科和儿科教职员工进行了身体整合。在这个新的管理结构下，1997年新增了450名成人患者和100名儿科患者。1997年进行了400例脑肿瘤开颅手术，1998年约有600名成人和400名儿童接受了原发脑瘤的随访。这项建议的具体目标是：1)在体外和临床前体内实验室研究的基础上，为脑瘤儿童设计创新的临床试验；2)在适当的患者积累、数据管理和监测的情况下进行这些试验。

The goals of the Brain Tumor Center at Duke are to foster interaction among a group of basic, translational, and clinical scientists to improve diagnosis and treatment of primary and metastatic brain tumors in adults and children and to train new basic, translational, and clinical investigators to work in Neuro-Oncology. The Brain Tumor Center at Duke (also called the Neuro-Oncology Program) is one of the oldest organ-site cancer programs at Duke and it predates the Cancer Center by a generation. The clinical and basic investigation in neuro- oncology at Duke began in 1937 under the leadership of the late Barnes Woodhall, M.D., first Professor of Neurosurgery at Duke and the second Chancellor of the Medical Center. Subsequent leaders of the Program were Guy L. Odom, M.D., James B. Duke Professor of Neurosurgery, and the late M. Stephen Mahaley, Jr., M.D. Dr. Darell Bigner has led the Program since its formal status as a Cancer Center Program was established more than 15 years ago when Core Grants initiated program status. The Neuro- Oncology Program is composed of 21 senior faculty who hold 23 peer-reviewed grants relative to neuro-oncology from the National Institute of Neurological Diseases and Stroke. The most significant progress in the ability to conduct clinical trials in adult and pediatric brain tumor patients at Duke was administrative reorganization of Clinical Neuro-Oncology to effectively merge surgical and medical care of both pediatric and adult patients. This important reorganization was envisioned and successfully negotiated with Duke Hospital, the relevant Department Chairs, and the Chancellor by the new Director of the Duke Comprehensive Cancer Center, O. Michael Colvin, M.D. First, in 1996, a Division of Pediatric Neuro-Oncology was created with Dr. Henry S Friedman as Chief with two additional pediatric neuro-oncology faculty. Dr. Friedman was then given appointments in both the Departments of Medicine and Surgery, and he and Dr. Allan Friedman, Chief of Neurosurgery, were made Co-Directors of Clinical Neuro-Oncology at Duke. The offices, data management staff, physician extenders, and medical and pediatric faculty staff were physically consolidated. With this new administrative structure 450 new adult patients, and 100 new pediatric patients were seen in 1997. There were 400 craniotomies for brain tumor performed in 1997, and approximately 600 adults and 400 children with primary brain tumors are being followed in 1998. The specific aims of this proposal are to 1) design innovative clinical trials for children with brain tumors based on in vitro and preclinical in vivo laboratory studies and 2) to conduct these trials with appropriate patient accrual, data management and monitoring.