NCT00585221

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

A Phase II Study Combining Targeted Therapy With Immunotherapy Using Imatinib Plus Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumors
• Cancer Brain
• Solid Tumors

Interventions

Type	Name	Description
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.
DRUG	Imatinib	Continue imatinib until progression.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-01-03
• Last updated: 2017-02-10
• Results posted: 2012-11-21

Locations

1 site across 1 country: United States