This Clinical Trials Core is established to identify relevant translational research, work with SPORE investigators to formulate hypothesis driven clinical investigations based on their discoveries, and provide the personnel/resources needed to support exploratory phase I/II clinical trials in patients with lung cancer. Research with a potential for clinical trial applications will be identified within the organizational structure of the SPORE. Robert A. Figlin, M.D., Director of Clinical Operations of the Core, will serve on the SPORE Executive Committee and Co-Chair the Developmental Programs Selection Committee, to assure that applicable projects are identified and prioritized. Similarly, Michael D. Roth, M.D., Director of Research Operations for the Core, will Co-Chair the Career Development Selection Committee. Once projects with clinical potential are identified, the Core Directors will meet with responsible investigators to collaborate in the formulation of testable clinical hypotheses. To implement clinical trials, a Core Administration and Support Staff will be developed, building upon existing resources available through the UCLA Thoracic Oncology and the Lung Cancer Research Programs. Supporting resources required to carry out clinical trials work will be obtained by interacting with the following established programs: 1) Thoracic Oncology Program and Jonsson Comprehensive Cancer Center's Clinical Research Unit; 2) Lung Cancer Research Program; 3) NIH-supported General Clinical Research Center's Clinical Research Unit; 2) Lung Cancer Research Program; 3) NIH-supported General Clinical Research Center; 4) Adoptive Immunotherapy Cell Culture Facility; 5) Pathology Human Tissue Research Center and Core; 6) Biostatistics Core; 7) UCLA Research and Drug Information Pharmacy; 8) Thoracic Imaging Division of Radiologic Sciences; 9) Thoracic Oncology Tumor Board; 10) Internal Scientific Peer Review Committee; 11) UCLA Institutional Review Board; 12) JCCC Quality Assurance Program; and 13) the established clinical programs, clinical programs, clinics and participating physicians from the Pulmonary & Critical Care Medicine, Hematology/Oncology, Thoracic Surgery and Radiation Oncology services within the Greater UCLA HealthCare System. Once projects have been formulated into working Clinical Protocols, funds will either be budgeted directly from the UCLA Lung Cancer SPORE to carry out exploratory phase I/II clinical trials or independent grants will be submitted for supplemental clinical trial support. Working in conjunction with the research staff from subproject 0004, the Clinical Trials Core has developed, and will carry out, an initial clinical trial entitled, """"""""A Phase I/II Trial Evaluating Intratumoral Injection of Interleukin-7 Gene-Modified Autologous Dendritic Cells for the Treatment of Non-Small Cell Lung Cancer.""""""""
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