New Approaches to Brain Tumor Therapy, NABTT CNS

描述（由申请人提供）：本提案的主要目的是通过继续作为全额资助的成员参与脑肿瘤治疗新方法（NABTT）CNS联盟的I期和II期临床研究，进一步努力改善恶性脑肿瘤成人患者的治疗和护理。该联盟利用10家优秀医疗机构的资源、专业知识和患者人群，这些医疗机构拥有经验丰富的多学科脑肿瘤项目，并证明有能力在这一具有挑战性的患者人群中评估新型治疗药物和方式。在过去6年的NABTT部分资助的临时成员，维克森林大学已经证明：（1）一个杰出的能力，积累新诊断或复发的高级别星形细胞瘤的成人患者的I期和II期临床试验的新的治疗药物;（2）具有收集、整理、监测和传输各种临床数据（包括组织样本）的出色能力，并以示范性和及时的方式这样做;和（3）在恶性脑肿瘤患者新治疗范例的构思、开发和实施中的科学领导。这一努力是对维克森林大学NCI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伸，该中心在过去25年中在概念开发、生物统计学、药理学、数据管理和患者招募方面表现出了专业知识。 本提案的第二个目的是分享我们的机构的兴趣和能力，收集，利用和分发脑肿瘤标本和其他临床材料与机构感兴趣的负责胶质瘤的发展和进展的分子事件，免疫组织化学和肿瘤的行为和治疗反应的分子预后标志物。我们继续期待这些努力所产生的新观察结果将导致这些肿瘤患者的总体生存率和生活质量的改善。

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.