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

$3,034M01FY2000RRNIH

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Linked publications & trials

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Abstract

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 IL-12 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 IL-10, IL-12 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.

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