NCT00880360

A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer

A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (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 tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.

Detailed description

This is a non-randomized, single-arm, Phase II trial. Selected patients with advanced-stage epithelial ovarian cancers who have no reasonable chance of cure using standard regimens, or who will not receive such regimens (due to contraindication or intolerance) are eligible. Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ontak	Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-04-13
• Last updated: 2018-03-27
• Results posted: 2012-10-19

Locations

1 site across 1 country: United States