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

Epithelial Ovarian Cancer Clinical Trial

— ONTAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880360
• Other study ID #: HSC20070042H
• Secondary ID: OCR 07-04
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2009
• Last updated: February 27, 2018
• Start date: February 2007
• Est. completion date: April 2010

Study information

• Verified date: January 2013
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00238186

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Epithelial Ovarian Cancer
• Extraovarian Peritoneal Cancer
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Ontak
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Locations

Country	Name	City	State
United States	CTRC at UTHSCSA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Demonstrating Clinical Response	Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.	2 years
Secondary	Toxicity	Determine any toxicity associated with Ontak treatment in these patients.	3 years