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Denileukin Diftitox in Treating Patients With Advanced Refractory Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

2014-07-23 21:35:40 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Conditions

Fallopian Tube Cancer

Intervention

denileukin diftitox

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
98109-1024

Status

Suspended

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:40-0400

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Extending the safety evidence for opportunistic salpingectomy in prevention of ovarian cancer: A cohort study from British Columbia, Canada.

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Medical and Biotech [MESH] Definitions

Diseases involving the FALLOPIAN TUBES including neoplasms (FALLOPIAN TUBE NEOPLASMS); SALPINGITIS; tubo-ovarian abscess; and blockage.

Methods for assessing the patency of the fallopian tubes.

Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk.

Formation of an artificial opening in a fallopian tube.

A pair of highly specialized muscular canals extending from the UTERUS to its corresponding OVARY. They provide the means for OVUM collection, and the site for the final maturation of gametes and FERTILIZATION. The fallopian tube consists of an interstitium, an isthmus, an ampulla, an infundibulum, and fimbriae. Its wall consists of three histologic layers: serous, muscular, and an internal mucosal layer lined with both ciliated and secretory cells.

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