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

Phase 2

Completed

• Conditions: Epithelial Ovarian Cancer; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma
• Interventions: Drug: Ontak

• Registration Number: NCT00880360
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2012-08-13
• Results First Submitted QC: 2012-09-19
• Results First Posted: 2012-10-19
• Status Verified: 2013-01
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• Able to provide informed consent
• Not on Immune modulating drugs
• Life expectancy less than 6 months

Exclusion Criteria

• Unable to tolerate phlebotomy
• Germ cell or stromal cell cancers of the ovaries
• Active autoimmune disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ontak	Ontak	Administration of Ontak IV for treatment of epithelial ovarian cancer

Primary Outcome Measures

Name	Time	Method
Number of Participants Demonstrating Clinical Response	2 years	Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.

Secondary Outcome Measures

Name	Time	Method
Toxicity	3 years	Determine any toxicity associated with Ontak treatment in these patients.

Trial Locations

Locations (1)

CTRC at UTHSCSA; 🇺🇸 San Antonio, Texas, United States