A Phase I Dose-Escalating Study of Recombinant Human Interleukin-12 (NSC # 672423) Administered by Intraperitoneal Infusion in Refractory Advanced Stage Ovarian Cancer and Other Abdominal Carcinomatosis
I. Assess the safety and maximum tolerated dose of recombinant human interleukin-12
(rhIL-12) administered by intraperitoneal infusion in patients with chemotherapy refractory
advanced ovarian cancer and other diffuse abdominal carcinomatosis.
II. Determine the immunopharmacologic profile of rhIL-12 in this patient population.
III. Evaluate the biologic response in selected patients to rhIL-12 administered through
OUTLINE: This is a dose escalation, multicenter study.
Cohorts of 3-6 patients each receive escalating doses of intraperitoneal recombinant human
interleukin-12 (rhIL-12) administered weekly for 9 weeks. If a patient tolerates rhIL-12 and
shows evidence of objective response or stable disease, patient may receive up to 9
additional weeks of treatment. Treatment continues in the absence of unacceptable toxicity
or disease progression. Dose escalation continues until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which no more than 1 of 6
patients experiences dose limiting toxicity.
All patients are followed for survival.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert P. Edwards, MD
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|