PH1 DOSE ESCALATING STUDY OF RECOMBINANT HUMAN INTERLEUKIN 12

$3,034M01FY2000RRNIH

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

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Abstract

This is an open-label, non-randomized, Phase I dose-escalating study of rhIL-12 administered by intraperitoneal (IP) infusion in adult male or female patients with measurable disseminated intraperitoneal cancer that is residual, recurrent or metastatic. Neither a control or placebo group will be utilized. The primary objectives are to assess the safety, mnaximum tolerated lose and therapeutic effect of IPIL-12 given by 3 hour infusion in patients with platinum refractory small volume intraperitoneal ovarian cancer. To test whether IPIL-12 can be given on an outpatient basis with sufficient support for management of side effects and sympton. Attempt to quantitate the immunopharmacology and biological impact of IPIL-12 on peripheral blood and peritoneal immunocyte populations by both markers of immune activation as well as ovarian cancer specific T-cell responses and natural killer cell activity.

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