Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients
|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: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|