Brief Title
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants Demonstrating Clinical Response
Secondary Outcome
Toxicity
Condition
Epithelial Ovarian Cancer
Intervention
Ontak
Study Arms / Comparison Groups
Ontak
Description: Administration of Ontak IV for treatment of epithelial ovarian cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
February 2007
Completion Date
April 2010
Primary Completion Date
April 2010
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tyler Curiel, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00880360
Organization ID
HSC20070042H
Secondary IDs
OCR 07-04
Responsible Party
Sponsor
Study Sponsor
The University of Texas Health Science Center at San Antonio
Study Sponsor
Tyler Curiel, MD, PhD, Principal Investigator, The University of Texas Health Science Center at San Antonio
Verification Date
January 2013