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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00880360
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : October 19, 2012
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Epithelial Ovarian Cancer
Extraovarian Peritoneal Cancer
Fallopian Tube Carcinoma
Intervention: Drug: Ontak

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11  57.9% 
>=65 years      8  42.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19 100.0% 
Male      0   0.0% 
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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: 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 ( Other Identifier: UTHSCSA )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: August 13, 2012
Results First Posted: October 19, 2012
Last Update Posted: December 5, 2017