New Approaches to Brain Tumor Therapy, NABTT CNS

描述(由申请人提供)：这项建议的主要目的是通过继续以全额资助成员的身份参与脑瘤治疗新方法(NABTT)CNS联盟的第一阶段和第二阶段临床研究，进一步努力改善成年恶性脑瘤患者的治疗和护理。该联盟利用10家优秀医疗机构的资源、专业知识和患者群体，这些机构拥有经验丰富的多学科脑瘤项目，并证明有能力在这一具有挑战性的患者群体中评估新的治疗药物和模式。在我们过去6年担任NABTT部分资助临时成员期间，维克森林大学已经证明：(1)吸引新诊断或复发的高级别星形细胞瘤成人患者参加新型治疗药物的I期和II期临床试验的出色能力；(2)收集、整理、监测和传输各种临床数据(包括组织样本)并以模范和及时的方式做到这一点的杰出能力；以及(3)在恶性脑瘤患者的新治疗模式的构思、开发和实施方面处于科学领先地位。这项工作是维克森林大学国家癌症研究所指定的综合癌症中心在临床研究和试验设计方面持续卓越传统的延续，该中心在过去25年中展示了概念开发、生物统计学、药理学、数据管理和患者收益方面的专业知识。 这项建议的第二个目的是分享我们在收集、利用和分发脑瘤标本和其他临床材料方面的机构兴趣和能力，这些机构对负责胶质瘤发展和进展的分子事件以及肿瘤行为和治疗反应的免疫组织化学和分子预后标记物感兴趣。我们继续期待从这些努力中产生的新的观察结果将导致患有这些肿瘤的患者的总体生存和生活质量的改善。

DESCRIPTION (provided by applicant): The primary aim of this proposal is to further our efforts to improve the treatment and care of adult patients with malignant brain tumors through continued participation as a fully funded member in the Phase I and II clinical investigations of the New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. This consortium utilizes the resources, expertise and patient populations of 10 outstanding medical institutions with experienced, multidisciplinary brain tumor programs and demonstrated ability to evaluate novel therapeutic agents and modalities in this challenging patient population. During our past 6 years of partially funded provisional membership in NABTT, Wake Forest University has demonstrated: (1) an outstanding ability to accrue adult patients with newly diagnosed or recurrent high grade astrocytomas to Phase I and II clinical trials of novel therapeutic agents; (2) an outstanding ability to collect, collate, monitor and transmit all manners of clinical data, including tissue samples, and to do so in an exemplary and timely fashion; and (3) scientific leadership in the conception, development and implementation of new treatment paradigms for patients with malignant brain tumors. This effort is an extension of the sustained tradition of excellence in clinical research and trial design on the part of the NCI-designated Comprehensive Cancer Center of Wake Forest University which has demonstrated expertise in concept development, biostatistics, pharmacology, data management and patient accrual over the past 25 years. A second aim of this proposal is to share our institutional interest in and ability to collect, utilize and distribute brain tumor specimens and other clinical material with institutions interested in the molecular events responsible for glioma development and progression, and the immunohistochemical and molecular prognostic markers of tumor behavior and response to therapy. We continue to expect that the novel observations which arise from these efforts will lead to improvements in both the overall survival and quality of life of our patients afflicted with these tumors.