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

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ClinicalTrials.gov Identifier: NCT00880360
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : October 19, 2012
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

April 10, 2009
April 13, 2009
August 13, 2012
October 19, 2012
March 27, 2018
February 2007
April 2010   (Final data collection date for primary outcome measure)
Number of Participants Demonstrating Clinical Response [ Time Frame: 2 years ]
Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
Not Provided
Complete list of historical versions of study NCT00880360 on ClinicalTrials.gov Archive Site
Toxicity [ Time Frame: 3 years ]
Determine any toxicity associated with Ontak treatment in these patients.
Not Provided
Not Provided
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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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Epithelial Ovarian Cancer
  • Extraovarian Peritoneal Cancer
  • Fallopian Tube Carcinoma
Drug: Ontak
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Other Name: Denileukin Diftitox
Experimental: Ontak
Administration of Ontak IV for treatment of epithelial ovarian cancer
Intervention: Drug: Ontak
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Not Provided
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00880360
HSC20070042H
OCR 07-04 ( Other Identifier: UTHSCSA )
Yes
Not Provided
Not Provided
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Not Provided
Principal Investigator: Tyler Curiel, MD, PhD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP