Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients
- Conditions
- Solid TumorsCancer BrainGastrointestinal Stromal Tumors
- Interventions
- Drug: Peginterferon-alpha 2b (PegIFNa2b);
- Registration Number
- NCT00585221
- Lead Sponsor
- University of Utah
- Brief Summary
Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can induce effective innate and adaptive anti-GIST immunity, which can eradicate imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with imatinib-sensitive GIST, leading to improved response rate and remission duration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients Peginterferon-alpha 2b (PegIFNa2b); All participants enrolled in the study. All patients Imatinib All participants enrolled in the study.
- Primary Outcome Measures
Name Time Method Decrease in Tumor Size. 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). two years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States