EFFECTS OF INTERLEUKIN-1-ALPHA ON OVARIAN-CARCINOMA IN PATIENTS WITH RECURRENT DISEASE

The aim of this study was to evaluate the safety and the biological ef fects of interleukin (IL-1 alpha) in patients with recurrent ovarian c arcinoma treated with carboplatin. In this phase I study, IL-1 alpha w as administered by a continuous intravenous infusion at doses ranging 0.1-10 mu g/m(2) every 24 h for 4 days (96 h) 3 weeks before the first dose of carboplatin (400 mg/m(2)) in patients with potentially platin um-sensitive ovarian cancer. The maximum tolerated dose was 3 mu g/m(2 )/day. Dose-limiting effects at 10 mu g/m(2)/day were fever, chills, h ypotension and fluid retention. Minor but objective antitumour effects were observed in 2 of 18 patients. 4 patients (including 1 with a min or response) had a decrease of the CA-125 serum level ranging from 33 to 39%. The trial design precluded evaluation of the duration of respo nse to single-agent IL-1 alpha. Based on this trial design, there is e vidence of minor antitumour effect to a single course of IL-1 alpha do se given prior to chemotherapy. Copyright (C) 1996 Elsevier Science Lt d