At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed malignant gastrointestinal stromal tumor, either primary (potentially resectable) or recurrent (potentially resectable with local or intra-abdominal/pelvic metastatic disease)
- ✓Documented c-kit (CD117) expression by immunohistochemistry from initial core specimen or (for recurrent disease) original tumor block
- ✓Primary disease must be visceral, intra-abdominal, or pelvic in origin
- ✓At least 1 unidimensionally measurable lesion (≥5 cm for primary, ≥2 cm for recurrent)
- ✕No uncontrolled chronic liver disease or uncontrolled chronic renal disease
- ✕No New York Heart Association class III or IV cardiac disease
- ✕No uncontrollable hyperglycemia
- ✕No severe or uncontrolled medical disease, active uncontrolled infection, or known/suspected hypersensitivity to study drug
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117)
In Brief
A Phase 2 clinical trial evaluating Conventional Surgery and Imatinib Mesylate for Gastrointestinal Stromal Tumor. Completed, enrolled 63 participants across 1 site.
Detailed Summary
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.
Study Details
Timeline
Interventions
Undergo surgical resection
Given orally