Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients
|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
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumors Cancer Brain Solid Tumors||Drug: Peginterferon-alpha 2b (PegIFNa2b); Drug: Imatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Combining Targeted Therapy With Immunotherapy Using Imatinib Plus Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
U.S. FDA Resources
Experimental: All patients
All participants enrolled in the study.
Drug: Peginterferon-alpha 2b (PegIFNa2b);
Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible.
Other Name: Trade name: Peg-IntronDrug: Imatinib
Continue imatinib until progression.
Other Name: Trade name: gleevec
- Decrease in Tumor Size. [ Time Frame: 18 months ]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 to Progression (TTP). [ Time Frame: two years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585221
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Lei Chen, MD||University of Utah|