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Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients

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ClinicalTrials.gov Identifier: NCT00585221
Recruitment Status : Terminated (PI terminated at the recommendation of DSMC & IRB)
First Posted : January 3, 2008
Results First Posted : November 21, 2012
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Stromal Tumors
Cancer Brain
Solid Tumors
Interventions Drug: Peginterferon-alpha 2b (PegIFNa2b);
Drug: Imatinib
Enrollment 8

Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All participants enrolled.
Period Title: Overall Study
Started 8
Completed 0
Not Completed 8
Reason Not Completed
Protocol Violation             8
Arm/Group Title Group 1
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  50.0%
>=65 years
4
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
64.875  (17.97)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Decrease in Tumor Size.
Hide Description Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All participants enrolled
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Time to Progression (TTP).
Hide Description [Not Specified]
Time Frame two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All participants enrolled
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 years
Adverse Event Reporting Description Study procedures were not completed on any of the 8 participants. There are no AEs to report.
 
Arm/Group Title All Enrolled
Hide Arm/Group Description All participants enrolled
All-Cause Mortality
All Enrolled
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Enrolled
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Enrolled
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Director of Clinical Trials
Organization: Huntsman Cancer Institute
Phone: 801-213-4241
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585221     History of Changes
Other Study ID Numbers: IRB_00022172
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: June 15, 2012
Results First Posted: November 21, 2012
Last Update Posted: February 10, 2017