Jay M. Lee, M.D. is an Assistant Professor of Surgery at UCLA with a clinical focus in lung cancer. His career goals are: 1) Research - To develop a scientific portfolio in translational application of investigator initiated therapies to clinical trials in lung cancer and to mature into an independent scientist who can successfully compete for funding. 2) Clinical - To become an academic leader in thoracic surgery known for patient oriented research. In order to achieve these goals, he will receive mentorship from Steven M. Dubinett, M.D. and James S. Economou, M.D., Ph.D., and the mentoring committee comprised of senior faculty members. He will be in a highly protected, stimulating research environment devoted to translational research in lung cancer He is enrolled in the UCLA K12 Clinical Scientist Training Program in Cancer Gene Medicine and will be enrolled in the UCLA K30 Graduate Training Program in Translational Investigation to receive a Master of Science degree in Clinical Researchwith an individualized didactic curriculum in Immunology. His research project entails the evaluation of dendritic cells, transduced with a replication- deficient adenoviral vector to express the secondary lymphoid organ chemokine gene (Ad-CCL-21-DC) to stimulate an anti-tumor immune response. The objectives of the study are 1) to determine the safety and maximum tolerated dose (MTD) of Ad-CCL-21-DC, 2) to determine the local and systemic biologic activity (i.e. generation of anti-tumor immune responses), and 3) to determine the clinical activity (i.e. reduction in tumor burden) when intratumorally injected into patients with non-small lung cancer (NSCLC). Patients with Stage IIIB or IV NSCLC with tumors accessible by CT-guided or bronchoscopic intervention, and are refractory to standard therapy will be enrolled into a_phase I, non-randomized, dose escalating, multi-cohort trial at a single institution. A total of 21 patients will be evaluated, 3 patients at each dose level, and an additional 12 patients at the MTD. The project has successfully received RAID and R21 """"""""Quick Trials"""""""" funding, RAC approval, and IND approval from the FDA.
(Seeinstructions): Lung cancer is the leading cause of cancer-related mortality in the United States with an attendant 15% overall survival at 5 years. Gene modified dendritic cell immunotherapy is a novel treatment strategy that addresses the need for new therapies in this disease.
