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
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.
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.
Number of Participants Demonstrating Clinical Response
Epithelial Ovarian Cancer
Study Arms / Comparison Groups
Description: Administration of Ontak IV for treatment of epithelial ovarian cancer
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
Tyler Curiel, MD, PhD, ,
The University of Texas Health Science Center at San Antonio
Tyler Curiel, MD, PhD, Principal Investigator, The University of Texas Health Science Center at San Antonio