PHASE II TRIAL OF IL 12 IN ADVANCED RECURRENT OR INOPERABLE CERVICAL

本研究的目的是：(1)确定晚期、复发或不能手术的宫颈癌患者对白介素12(IL-12)治疗的客观应答率、反应持续时间和生存时间；(2)确定IL-12系统治疗的毒性；(3)将IL-12治疗的反应和总存活率与HPV的存在与否和HPV的特定亚型相关联；(4)评估IL-12对治疗前后免疫参数的影响，特别是对E6和E7表位的淋巴增殖反应、TH1功能、以及外周血单核细胞中特定细胞因子的诱导水平，包括IL-2和干扰素-γ，以及通过测试丝裂原反应和标准召回抗原的一般细胞介导的免疫状态。

The objectives of this study are: (1) to determine the objective response rates, duration of response and survival in women with advanced, recurrent or inoperable carcinoma of the cervix to interleukin-12 (IL-12) therapy, (2) to determine the toxicities of systemic therapy with IL-12, (3) to correlate response to therapy with IL-12 and overall survival with the presence or absence of human papillomavirus (HPV), and the specific subtype of the HPV, and (4) to assess effects of IL-12 on immune parameters prior to and following treatment, specifically: lymphoproliferative response to E6 and E7 epitopes, TH1 function, and levels of specific cytokine induction in peripheral blood mononuclear cells, including IL-2 and interferon-gamma, and general cell-mediated immune status by testing mitogen responses and standard recall antigens.