Therapeutic Studies of Primary CNS Malignancies-NABTT

描述(申请人提供)：克利夫兰临床癌症中心脑瘤研究所(BTI)的一个主要目的是通过基础科学促进对脑瘤发展和生长机制的了解，并通过与工业和临床研究的工程合作开发新的治疗方案。我们认为，长期加入NABTT联合体将是我们实现这一目标的主要手段。BTI每年进行600多例脑肿瘤手术，其中约150例针对恶性胶质肿瘤。通过BTI的转化治疗中心，我们对新的、有前途的脑肿瘤药物进行临床前测试，确定它们的有效性和最佳给药方式。其他转化性实验室工作包括脑肿瘤的过继免疫治疗和免疫系统调节、对流增强潜在治疗方法的提供、血清肿瘤标志物的检测、脑图像后处理或多模式集成以及用于评估治疗效果的纵向自动分割和融合。我们打算向NABTT财团提供有前途的新代理人和我们在这些领域的专业知识。 自从两年前被NABTT接纳为临时成员以来，我们通过参与或领导NABTT委员会、方案领导，并在任何活跃的NABTT站点中拥有最高的第二年收益，第三年预计收益约为28名患者，表明了我们对该组织的承诺。我们相信，我们每年对NABTT联盟的患者贡献将在每年25到30人之间。对该联盟的其他贡献将包括1)具有临床前疗效证据和最佳给药途径的新药物，2)脑瘤治疗免疫策略的专业知识，3)整合脑成像和跟踪随时间变化的新方法，4)对流增强递送等高级药物递送策略的专业知识，5)放射治疗、放射外科、外科导航和神经成像方面的广泛专业知识和最新资源，6)能够与其他NABTT实验室对接的广泛的、赠款和捐赠支持的基础科学工作，7)具有IRB批准的临床/病理学/分子/成像数据库关联的大型肿瘤库，8)我们在产生和完成第一阶段和第二阶段临床试验方面的专业知识。

DESCRIPTION (provided by applicant): A major thrust of The Brain Tumor Institute (BTI) of the Cleveland Clinic Cancer Center is to advance knowledge of the mechanisms of brain tumor development and growth, through basic science, and to develop new treatment options, by way of engineering collaboration with industry and clinical research. We believe that an ongoing, long-term membership in the NABTT consortium will be our principal means of achieving this goal. The BTI performs more than 600 brain tumor operations per year, of which approximately 150 are on malignant glial neoplasms. Through BTI's Center for Translational Therapeutics, we perform preclinical testing of new, promising brain tumor agents, determining their efficacy and optimum mode of delivery. Additional translational laboratory efforts include adoptive immunotherapy and immune system regulation for brain tumors, convection enhanced delivery of potential therapies, detection of serum tumor markers, and brain image post-processing or multimodality integration and longitudinal autosegmentation and fusion for assessment of treatment efficacy. It is our intention to contribute promising new agents and our expertise in these areas to the NABTT consortium. Since being accepted as a provisional member in NABTT 2 years ago, we have demonstrated our commitment to this organization by participating in or leading NABTT committees, protocol leadership, and having the highest second-year accrual of any active NABTT site, with a third-year projected accrual of about 28 patients. We believe that our yearly contribution of patients to the NABTT consortium will be in the range of 25 to 30 per year. Additional contributions to the Consortium will include 1) new agents with preclinical evidence of efficacy and optimal route of administration, 2) expertise in immunological strategies for brain tumor treatment, 3) new methods of integrating brain imaging and tracking changes over time, 4) expertise in advanced-agent delivery strategies such as convection enhanced delivery, 5) extensive expertise and state-of-art resources in radiotherapy, radiosurgery, surgical navigation, and neuro-imaging, 6) a broad, grant and endowment-supported basic science effort with capability to interface with other NABTT laboratories, 7) a large tumor bank with IRB-approved clinical/pathology/molecular/imaging database correlations, and 8) our expertise in generating and completing Phase I and II clinical trials.