Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK® Administered to Patients With Advanced Stage Ovarian Cancer
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose of intraperitoneal
administration of ONTAK. SECONDARY OBJECTIVES: I. To evaluate the change in the number of
Tregs in the peritoneum with the administration of ONTAK. II. To evaluate the change in the
number of Tregs in the peripheral blood with the administration of ONTAK. III. To assess the
clinical impact of ONTAK on tumor burden by serial measurements of CA-125. IV. To assess the
level of circulating cytokines IL-2, IL-6, IL-10, TGF-beta2, and TNF-alpha in the peritoneum
and peripheral blood before and after I.P. ONTAK. OUTLINE: This is a dose escalation study.
Patients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3.
Treatment repeats every 14 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of denileukin
diftitox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After the
completion of study treatment, patients are followed up at 1 and 2 weeks, monthly for 3
months, and then at 6 months.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity profile as assessed by the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events version 3.0
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|