NABTC Central Operation Grant (UCSF Project Leader)

描述(申请人提供)：北美脑瘤联合会(NABTC)成立于1993年，一直在为恶性脑瘤患者进行早期临床试验。NABTC的中央运营办公室/协调中心设在加州大学旧金山分校，由马里兰州迈克尔·普拉多斯领导。加州大学旧金山分校中央业务办公室/协调中心将继续协调NABTC参与成员机构和药代动力学中心的科学和行政活动。NABTC将由来自美国各地的7个正式成员机构、NCI/NINDS神经肿瘤学分部的一个非资助成员机构和德克萨斯大学圣安东尼奥大学的1个药代动力学中心组成。NABTC将与癌症治疗部门的癌症治疗评估计划(CTEP)和辐射研究计划(RRP)协调努力，在这一患者群体中进行新的治疗。中央业务办公室/协调中心将提供行政管理，协调方案的制定和提交，进行研究，质量控制，方案性能监测，统计分析，遵守关于NCI药物问责、FDA、OHRP和HHS条例的要求，以及方案和机构业绩报告。作为小组负责人，Prados博士将在CTEP的协助下监督NABTC的科学、临床和行政活动，以实现NABTC的目标。NABTC的数据管理将继续由MD Anderson癌症中心数据管理中心的分包合同提供支持。NABTC中央业务办公室/协调中心的目标将是确保在进行中的和新的临床试验期间进行高质量的研究，并对具有潜在临床意义的中枢神经系统肿瘤生物学方面进行辅助实验室调查。在此次续签申请中，NABTC还将计划与其他资助的成人(NABTT)和儿童(PBTC)脑瘤联盟、人类癌症联盟的小鼠模型、最近资助的脑瘤孢子机构(加州大学旧金山分校和阿拉巴马大学)以及NIH/NCI的内科神经肿瘤科进行互动。NABTC在中央业务办公室/协调中心、其成员机构和药代动力学中心的协助下，在过去9年中进行了良好的合作，在过去5年中积累了近1000名患者参加I期和II期早期研究，并寻求在未来5年进一步加强这一努力。NABTC将使用新的治疗药物治疗患者，最终目标是提高质量，并有望提高这一患者群体的总存活率。

DESCRIPTION (provided by applicant): The North American Brain Tumor Consortium (NABTC) was formed in 1993 and has continuously conducted early phase clinical trials for patients with malignant brain tumors. The Central Operations Office/Coordinating Center for the NABTC is at the University of California San Francisco (UCSF) under the Group Leadership of Michael Prados, MD. The UCSF Central Operations Office/Coordinating Center for this renewal grant application will continue to coordinate the scientific and administrative activities of the Participating Member Institutions and Pharmacokinetics Center of the NABTC. The NABTC will be composed of 7 full Member Institutions from across the United States, a non-funded Member Institution at the NCI/NINDS Neuro-Oncology Branch, and 1 Pharmacokinetics Center at the University of Texas San Antonio. The NABTC will coordinate its efforts with the Cancer Therapy Evaluations Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Therapy to conduct novel therapies in this patient population. The Central Operations Office/Coordinating Center will provide administrative management, coordination of protocol development and submissions, study conduct, quality control, protocol performance monitoring, statistical analysis, adherence to requirements regarding NCI drug accountability, FDA, OHRP and HHS regulations, and protocol and institutional performance reporting. As Group Leader, Dr. Prados will oversee the scientific, clinical and administrative activities of the NABTC, with the assistance of CTEP, in order to achieve the NABTC goals. Data Management for the NABTC will continue to be supported by a subcontract with the MD Anderson Cancer Center Data Management Center. The goal of the NABTC Central Operations Office/Coordinating Center will be to assure high quality research during the conduct of ongoing and new novel clinical trials and to perform ancillary laboratory investigations of aspects of CNS tumor biology with potential clinical implications. In this renewal application, the NABTC will also plan to interact with the other funded adult (NABTT) and pediatric (PBTC) brain tumor consortia, the Mouse Models of Human Cancer Consortium, the recently funded Brain Tumor SPORE institutions (UCSF and University of Alabama), and the intramural Neuro-Oncology Branch at the NIH/NCI. The NABTC, with the assistance of the Central Operations Office/Coordinating Center, its Member Institutions and Pharmacokinetics Center, has worked well together over the last 9 years, accruing nearly 1000 patients to phase I and early phase II studies in the last 5 years, and seeks to further enhance this effort in the next 5 years. The NABTC will treat patients using novel therapeutic agents with the ultimate goal to increase quality, and hopefully, overall survival in this patient population.