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 : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma||Drug: Ontak||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2007|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Other Name: Denileukin Diftitox
- 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.
- Toxicity [ Time Frame: 3 years ]Determine any toxicity associated with Ontak treatment in these patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880360
|United States, Texas|
|CTRC at UTHSCSA|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Tyler Curiel, MD, PhD||The University of Texas Health Science Center at San Antonio|