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

这是一项II期IL-12基因治疗头颈癌的研究，采用直接注射肿瘤与基因工程自体成纤维细胞。 本研究的目的是：1）确定通过瘤周注射自体成纤维细胞递送的离体IL 12基因治疗在头颈癌中是否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，具体地：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。 和5）鉴定临床、病理学或免疫学应答的可能的预处理预测因子。

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 IL12 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 IL10, IL12 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.