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

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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.