A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer (ONTAK)
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.
Epithelial Ovarian Cancer
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
- Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Determine any toxicity associated with Ontak treatment in these patients.
|Study Start Date:||February 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Other Name: Denileukin Diftitox
|United States, Texas|
|CTRC at UTHSCSA|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Tyler Curiel, MD, PhD||University of Texas Health Science Center at San Antonio|