A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
ONTAK
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
2 other identifiers
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
October 19, 2012
CompletedMarch 27, 2018
January 1, 2013
3.2 years
April 10, 2009
August 13, 2012
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Demonstrating Clinical Response
Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
2 years
Secondary Outcomes (1)
Toxicity
3 years
Study Arms (1)
Ontak
EXPERIMENTALAdministration of Ontak IV for treatment of epithelial ovarian cancer
Interventions
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Eligibility Criteria
You may qualify if:
- Able to provide informed consent
- Not on Immune modulating drugs
- Life expectancy less than 6 months
You may not qualify if:
- Unable to tolerate phlebotomy
- Germ cell or stromal cell cancers of the ovaries
- Active autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CTRC at UTHSCSA
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tyler Curiel
- Organization
- University of Texas Health Science Center at San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Tyler Curiel, MD, PhD
The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
February 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
March 27, 2018
Results First Posted
October 19, 2012
Record last verified: 2013-01