This is a Phase II, IL-12 gene therapy for melanoma using direct injection of tumors with genetically engineered autologous fibroblasts study. The aims of this study are 1) to determine whether ex-vivo IL-12 gene therapy delivered via peri-tumorally injected autologous fibroblasts has clinical antitumor activity in melanoma; 2) to characterize local immunomodulatory effects of this procedure; 3) to characterize the systemic immunomodulatory effects of this procedure, specifically serum IL-10, IL-12 and IFNy 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.
NIH ExPorter
NIH ExPorter