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Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00112632
Enrollment
40
Registered
2005-06-03
Start date
2005-02-28
Completion date
Unknown
Last updated
2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor

Brief summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.

Detailed description

OBJECTIVES: Primary * Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate. * Determine histological response in patients treated with this drug. Secondary * Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug. * Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug. * Determine the safety and tolerability of this drug in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Interventions

DRUGimatinib mesylate
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed gastrointestinal stromal tumor * Locally advanced disease * Potentially resectable disease\* * No tumor that can be completely resected (R0) with sufficient margins NOTE: \*Multivisceral resection may be necessary * Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry * At least 1 site of measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 Hepatic * AST and ALT \< 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present) * Bilirubin \< 1.5 times ULN * No chronic active hepatitis * No cirrhosis * No other chronic liver disease Renal * Creatinine \< 1.5 times ULN * No chronic renal disease Cardiovascular * No New York Heart Association class III-IV cardiac disease * No congestive heart failure * No myocardial infarction within the past 6 months Immunology * No active uncontrolled infection * No known HIV positivity Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment * Must be medically fit to undergo surgery * No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention * No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention * No uncontrolled diabetes * No other severe or uncontrolled medical disease * No significant history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic agents Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing * No concurrent anticancer chemotherapy Endocrine therapy * No concurrent systemic corticosteroid therapy unless approved by the study sponsor Radiotherapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to ≥ 25% of bone marrow Surgery * More than 2 weeks since prior major surgery except tumor biopsy Other * More than 4 weeks since prior investigational drugs unless disease is rapidly progressing * No other concurrent anticancer therapy * No other concurrent investigational agents * No concurrent warfarin for therapeutic anticoagulation * Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed * Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed

Design outcomes

Primary

MeasureTime frame
Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary

MeasureTime frame
Time to progression of disease
Overall survival

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026