Core--Clinical trials

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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.