Core--Clinical trials

描述：(申请人提供) 这项研究提案的主要目标是开发技术来评估 使用(1)创新的免疫组织化学和免疫组织化学方法研究患者血管生成 我们实验室开发的生化测试和(2)非侵入性成像。 以验证这些技术是否可以应用于临床开发 在抗血管生成治疗方面，我们将评估候选的生化分析和 通过正在进行的和拟议的临床前和 本提案中概述的临床试验。临床试验的核心将是 管理诊所、药理实验室之间的接口(资助 另外，U01 CA6246I PI：Abruzzese)和瓷砖研究实验室。 四个研究项目中的每一个都将利用患者样本或成像 来自四个正在进行或计划中的临床试验之一的研究。四个临床 试验将用于研究和验证开发的方法，以评估 实验室开发的新型药物的抗血管生成作用 在此应用程序上进行协作。这些措施包括：(1)第二阶段试验 抗EGF抗体C225+吉西他滨在胰腺癌中的应用 小分子EGFR酪氨酸激酶抑制剂PKII66的I期试验，(3) 人内皮抑素的I期试验，(4)和拟议的I期研究 小分子受体酪氨酸激酶抑制剂SU6668，一种能够 抑制血管内皮生长因子、碱性成纤维细胞生长因子和血小板衍生生长因子受体。临床试验的核心 将负责组织和分发瓦片临床标本 从这些研究中获得，包括为生物学目的而获得的肿瘤活检 研究，因此，将与核心B(生物统计--HESS)密切联系， 核心C(组织病理学实验室--布卡纳)和核心E(成像 资源-史高丽)。此外，临床试验核心将组织 任何临床试验中与发育相关的患者的成像 项目2至5。 总而言之，临床试验核心的具体任务将是(1) 开发高质量的临床试验，旨在实现 研究项目和开发项目的目标，(2)协调 获取肿瘤活检和其他临床标本，(3)协调 诊断影像研究的获取、分发和分析，(4) 协调与药理学的互动，促进药效学 数据分析。(5)提供数据监控和协调审计。

Description: (provided by applicant) The primary goal of this research proposal is to develop techniques to assess angiogenesis in patients using, (1) innovative immunohistochemical and biochemical tests developed in our laboratories and, (2) non-invasive imaging. To validate that these techniques can be applied to the clinical development of antiangiogenic therapies, we will assess candidate biochemical assays and noninvasive techniques through the ongoing and proposed preclinical and clinical trials outlined in this proposal. The Clinical Trials Core will manage the interface between the clinic, pharmacology laboratories (funded separately U01 CA6246I PI: Abbruzzese), and tile research laboratories. Each of the four Research Projects will utilize patient specimens or imaging studies from one of four on-going or planned clinical trials. Four clinical trials will be used to study and validate methods developed to assess the antiangiogenic effects of novel agents developed in the laboratories collaborating on this application. These include: (1) A phase II trial of the anti-EGF antibody C225 + Gemcitabine in patients with pancreatic cancer, (2) A phase I trial of the small molecule EGFR tyrosine kinase inhibitor PKII66, (3) A phase I trial of human endostatin, (4) and the proposed phase I study of tile small molecule receptor tyrosine kinase inhibitor SU6668, an agent that inhibits the VEGF, basic FGF , and PDGF receptors. The Clinical Trials Core will be responsible for organizing and distributing tile clinical specimens obtained from these studies including tumor biopsies obtained for biological studies, and will, therefore, interface closely with Core B (Biostatistics -Hess), Core C (Histopathology Laboratory - Bucana), and Core E (Imaging Resources - Scully). In addition, the Clinical Trials Core will organize the imaging of patients on any clinical trails interfacing with Developmental Projects 2 through 5. In summary, the specific tasks of the Clinical Trials Core will be to (1) develop high quality clinical trials designed to accomplish the translational aims of the research projects and developmental projects, (2) coordinate acquisition of tumor biopsy and other clinical specimens, (3) coordinate the acquisition, distribution and analysis of diagnostic imaging studies, ( 4) coordinate interactions with pharmacology to facilitate pharmacodynamic analysis of data. (5) Provide data monitoring and coordinate audits.