NCT01773889

A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer

A Phase II Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, Extraovarian Peritoneal or Fallopian Tube Carcinoma or Ineligible for First-Line Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatment efficacy.

Detailed description

The aims of this study are to: * Assess the efficacy of adding pegylated IFN-α2b to denileukin diftitox to treat selected advanced-stage epithelial ovarian cancers * Test the immune-modulating effects of adding pegylated IFN-α2b to denileukin diftitox in ovarian cancer patients and relate them to clinical efficacy * Identify any toxicity associated with pegylated IFN-α2b plus denileukin diftitox treatment in these patients * Identify practical means to dose the immunomodulating agents denileukin diftitox and pegylated IFN-α2b based on immunopharmacodynamic metrics

Conditions

• Epithelial Ovarian Cancer
• Extraovarian Peritoneal Cancer
• Fallopian Tube Carcinoma

Interventions

Type	Name	Description
DRUG	Denileukin Diftitox/SC Pegylated IFNα-2a

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2013-01-23
• Last updated: 2018-04-10
• Results posted: 2013-07-02

Locations

1 site across 1 country: United States