PEDIATRIC BRAIN TUMOR CLINICAL TRIALS CONSORTIUM

杜克大学脑肿瘤中心的目标是促进基础、转化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，并培养新的基础、转化和临床研究人员在神经肿瘤学领域工作。杜克大学的脑肿瘤中心（也被称为神经肿瘤学项目）是杜克大学最古老的器官肿瘤项目之一，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，在已故巴恩斯·伍德霍尔医学博士的领导下，他是杜克大学第一位神经外科教授和医学中心的第二任校长。该项目的后续领导人是Guy L. Odom，医学博士，James B. Duke神经外科教授，以及已故的M. Stephen Mahaley, Jr.医学博士。Darell Bigner博士自15年前Core Grants启动该项目以来，一直领导该项目作为癌症中心项目的正式地位。神经肿瘤学项目由21名高级教师组成，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审补助金。在杜克大学进行成人和儿童脑肿瘤患者临床试验的能力方面，最重要的进展是临床神经肿瘤学的行政重组，以有效地合并儿科和成人患者的外科和医疗护理。这一重要的重组是由杜克综合癌症中心的新主任，O. Michael Colvin， M.D.与杜克医院，相关系主任和校长成功协商的。首先，在1996年，儿科神经肿瘤科成立，Henry S Friedman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学的联合主任。办公室、数据管理人员、医师扩展人员以及医疗和儿科教职人员进行了实际合并。在这种新的管理结构下，1997年有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年随访了大约600名患有原发性脑瘤的成人和400名儿童。本提案的具体目标是：1)基于体外和临床前体内实验室研究，为患有脑肿瘤的儿童设计创新的临床试验；2)在适当的患者累积、数据管理和监测下进行这些试验。

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.