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

这是一项II期，IL-12基因治疗黑色素瘤的研究，采用基因工程自体成纤维细胞直接注射肿瘤。 本研究的目的是1）确定通过肿瘤周围注射的自体成纤维细胞递送的离体IL-12基因疗法是否在黑素瘤中具有临床抗肿瘤活性; 2）表征该程序的局部免疫调节作用; 3）表征该程序的全身免疫调节作用，特别是血清IL-10、IL-12和IFN γ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，以及5）鉴定临床、病理或免疫反应的可能的预处理预测因子。

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.