PEDIATRIC BRAIN TUMOR CLINICAL TRIALS CONSORTIUM

杜克大学脑肿瘤中心的目标是促进一组基础，翻译和临床科学家之间的互动，以改善成人和儿童原发性和转移性脑肿瘤的诊断和治疗，并培训新的基础，翻译和临床研究人员在神经肿瘤学工作。 杜克的脑肿瘤中心（也称为神经肿瘤学项目）是杜克最古老的器官部位癌症项目之一，它比癌症中心早了一代人。 杜克大学神经肿瘤学的临床和基础研究始于1937年，由已故的医学博士巴恩斯伍德霍尔领导，他是杜克大学的第一任神经外科教授和医学中心的第二任校长。 该计划的后续领导人是Guy L。奥多姆医学博士詹姆斯B。神经外科杜克教授和已故的M。小斯蒂芬·马哈利，M.D. Darell Bigner博士领导了该计划，因为它作为癌症中心计划的正式地位是在15年前核心赠款启动计划地位时建立的。 神经肿瘤学项目由21名高级教师组成，他们拥有23项来自国家神经疾病和中风研究所的神经肿瘤学同行评审赠款。 在杜克对成人和儿童脑肿瘤患者进行临床试验的能力方面，最重要的进展是对临床神经肿瘤学进行了行政重组，以有效地合并儿童和成人患者的手术和医疗护理。 杜克大学综合癌症中心的新任主任O。Michael Colvin，医学博士 首先，在1996年，儿科神经肿瘤科成立，亨利S弗里德曼博士担任主任，另外还有两名儿科神经肿瘤科教师。 弗里德曼博士随后被任命为内科和外科两个部门的负责人，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学的联合主任。 办公室，数据管理人员，医生扩展器，以及医疗和儿科教职员工进行了物理合并。 在这一新的管理结构下，1997年共收治了450名新的成人患者和100名新的儿科患者。 1997年进行了400例脑瘤开颅手术，1998年对患有原发性脑瘤的大约600名成人和400名儿童进行了跟踪。 本提案的具体目的是：1）基于体外和临床前体内实验室研究，为脑肿瘤儿童设计创新性临床试验; 2）在适当的患者招募、数据管理和监测下开展这些试验。

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.