CLINICAL STUDIES/TRIALS

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This Clinical Studies/Trials Project is based on accomplishment over the past several years and continues to support two major initiatives (1) intensification of chemotherapy by regional Infusion" of the lung for patients with Soft Tissue Sarcoma metastatic to the lung. (2) Preclinical and clinical immunologic studies of high risk STS patients. In section 1a, phase I and phase II trials are ongoing and planned. Tissue obtained from patients in these studies will be sent to investigators in project 1b, 2, and 3 for analysis of tumor antigens, cell cycle regulators and mechanisms of drug resistance. In section 1b, preclinical studies are planned to define novel approaches for the development of tumor vaccines in order to delay or prevent progression of disease. Little is known about potential target on STS, except gangliosides and SYT_SSX fusion proteins, both under study in this Program Project. Therefore, we plan to identify antigens expressed by screening DNA libraries derived from autologous tumors, investigate peptide and DNA immunization against SYT_SSX fusion proteins, and evaluate immunizations against combinations of gangliosides in high risk patients. ?