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，使用基因工程的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给药的离体IL-12基因治疗在黑色素瘤中是否具有临床抗肿瘤活性；2)描述该手术的局部免疫调节作用；3)表征该手术的全身免疫调节作用，特别是血清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)确定临床、病理或免疫反应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.