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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tyler Curiel, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00880360
First received: April 10, 2009
Last updated: January 7, 2013
Last verified: January 2013

April 10, 2009
January 7, 2013
February 2007
April 2010   (final data collection date for primary outcome measure)
Number of Participants Demonstrating Clinical Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Determine any toxicity associated with Ontak treatment in these patients.
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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
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
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880360
HSC20070042H, OCR 07-04
Yes
Tyler Curiel, The University of Texas Health Science Center at San Antonio
Tyler Curiel
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