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Trial record 73 of 2832 for:    Pancreatic Cancer

A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer

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: NCT00726037
Recruitment Status : Terminated (Collaborator withdrew support due to a drug supply interruption.)
First Posted : July 31, 2008
Results First Posted : August 24, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborators:
Riveria Country Club Organization
Eisai Inc.
Information provided by (Responsible Party):
Loyola University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Intervention Drug: Ontak
Enrollment 7
Recruitment Details Recruitment for this study began on 06/18/2008 and ended on 01/09/2012
Pre-assignment Details  
Arm/Group Title Ontak
Hide Arm/Group Description Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Ontak
Hide Arm/Group Description Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer
Hide Description The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.
Time Frame days 8, 12 ,19,26 and 33 post administration
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption
Arm/Group Title Ontak
Hide Arm/Group Description:
Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Optimal Time for Future Dendritic Cell Vaccine Administration
Hide Description The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration
Time Frame 33 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption
Arm/Group Title Ontak
Hide Arm/Group Description:
Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame For each participant, adverse events were assessed from baseline through end of study (i.e., 33 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ontak
Hide Arm/Group Description Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
All-Cause Mortality
Ontak
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ontak
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ontak
Affected / at Risk (%)
Total   0/7 (0.00%) 
This study was prematurely terminated, because the study drug Ontak is no longer supplied by the manufacturer for this study. Data is not analyzed for any outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Margret Shoup
Organization: Northwestern Medicine Regional Medical Group
Phone: 630-352-5450
Publications:
Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00726037     History of Changes
Other Study ID Numbers: 200732
First Submitted: July 29, 2008
First Posted: July 31, 2008
Results First Submitted: April 26, 2013
Results First Posted: August 24, 2016
Last Update Posted: September 29, 2016