Back to resultsA Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer (ONTAK)
Primary Purpose
Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ontak
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Epithelial Ovarian Cancer, FIGO (International Fed of Gyn and Ob)Stage III or Stage IV, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma Failing
Eligibility Criteria
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
Sites / Locations
- CTRC at UTHSCSA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ontak
Arm Description
Administration of Ontak IV for treatment of epithelial ovarian cancer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Toxicity
Determine any toxicity associated with Ontak treatment in these patients.
Full Information
NCT ID
NCT00880360
First Posted
April 10, 2009
Last Updated
February 27, 2018
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00880360
Brief Title
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma
Keywords
Epithelial Ovarian Cancer, FIGO (International Fed of Gyn and Ob)Stage III or Stage IV, Extraovarian Peritoneal Cancer, Fallopian Tube Carcinoma Failing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ontak
Arm Type
Experimental
Arm Description
Administration of Ontak IV for treatment of epithelial ovarian cancer
Intervention Type
Drug
Intervention Name(s)
Ontak
Other Intervention Name(s)
Denileukin Diftitox
Intervention Description
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating Clinical Response
Description
Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Toxicity
Description
Determine any toxicity associated with Ontak treatment in these patients.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler Curiel, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTRC at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
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