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RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox when given as an intraperitoneal infusion in treating patients with advanced refractory ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
- Estimate the maximum tolerated dose of intraperitoneal administration of denileukin diftitox in patients with advanced refractory ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
- Evaluate the change in the number of T-regulatory cells in the peritoneum and peripheral blood of patients treated with intraperitoneal denileukin diftitox.
- Assess the clinical impact of denileukin diftitox on tumor burden by serial measurements of CA-125 in these patients.
- Assess the level of circulating cytokines (aldesleukin, interleukin [IL]-6, IL-10, transforming growth factor [TGF]-β2, and tumor necrosis factor [TNF]-α) in the peritoneum and peripheral blood before and after treatment.
OUTLINE: This is a non-randomized, dose-escalation study.
Patients receive intraperitoneal denileukin diftitox over 15 minutes on days 1-3. Treatment repeats every 14 days for up to 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 at 1 and 2 weeks, monthly for 3 months, and then at 6 months.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Allocation: Non-Randomized, Primary Purpose: Treatment
Fallopian Tube Cancer
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:35:40-0400
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