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
Results First Received: August 13, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma
Intervention: Drug: Ontak

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ontak Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Participant Flow:   Overall Study
    Ontak  
STARTED     19  
COMPLETED     19  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ontak Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.

Baseline Measures
    Ontak  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     8  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 1  
Gender  
[units: participants]
 
Female     19  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     19  



  Outcome Measures

1.  Primary:   Number of Participants Demonstrating Clinical Response   [ Time Frame: 2 years ]

2.  Secondary:   Toxicity   [ Time Frame: 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Tyler Curiel
Organization: University of Texas Health Science Center at San Antonio
phone: 210-450-1000
e-mail: curielt@uthscsa.edu


No publications provided


Responsible Party: Tyler Curiel, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00880360     History of Changes
Obsolete Identifiers: NCT00238186
Other Study ID Numbers: HSC20070042H, OCR 07-04
Study First Received: April 10, 2009
Results First Received: August 13, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board