PH II IL 12 GENE THERAPY MELANOMA INJECTION OF TUMORS WITH AUTO FIBROBLAST

这是一项使用基因工程自体成纤维细胞直接注射肿瘤的第二阶段IL-12基因治疗黑色素瘤的研究。本研究的目的是1)确定通过瘤周注射自体成纤维细胞进行的IL-12基因治疗是否对黑色素瘤具有临床抗肿瘤活性；2)表征这一过程的局部免疫调节作用；3)表征这一过程的全身性免疫调节效应，尤其是血清IL-10、IL-12和IFNy水平；4)表征免疫调节措施之间以及这些措施与临床指标或反应之间的相关性；5)确定可能的临床、病理或免疫反应的预处理预测因素。

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.