IL 12 GENE THERAPY HEAD/NECK CANCER TUMORS W/ AUTOLOGOUS FIBROBLASTS

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This is a Phase II IL-12 gene therapy for head and neck cancer using direct injection of tumors with genetically engineered autologous fibroblasts study. The aims of this study are 1)to determine whether ex-vivo IL12 gene therapy delivered via peritumorally injected autologous fibroblasts has clinical antitumor activity in head and neck cancer. 2)to characterize the local immunomodulatory effects of this procedure. 3)to characterize the systemic immunomodulatory effects of this procedure, specifically: serum IL10, IL12 and IFN-y levels. 4)to characterize the correlations among immuno-modulation measures and between those measures and clinical indicators or response. and 5)to identify possible pretreatment predictors of clinical, pathologic or immunologic response.