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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
Study ID: NCT00880360
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
CTRC at UTHSCSA, San Antonio, Texas, United States
Name: Tyler Curiel, MD, PhD
Affiliation: The University of Texas Health Science Center at San Antonio
Role: PRINCIPAL_INVESTIGATOR