Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborator: Niigata University Medical & Dental Hospital
• Treatments: Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of gastrointestinal stromal tumor (GIST)

• Hepatic metastasis meeting the following criteria:

• No more than 3 hepatic metastases

• Clinically diagnosed as surgically resectable with no macroscopic residual tumor

• Synchronous hepatic metastasis allowed provided primary tumor is also resectable

• No metastatic tumor that requires radiofrequency ablation and/or microwave coagulation therapy to control the disease

• No extrahepatic metastasis

• No history of GIST recurrence

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Leukocyte count ≥ 3,000/μL

• Neutrophil count ≥ 1,500/μL

• Hemoglobin ≥ 8.0 g/dL

• Platelet count ≥ 75,000/μL

• Total bilirubin ≤ 2.0 mg/dL

• ALT and AST < 120 IU/L

• GTP < 210 IU/L

• Not pregnant

• No poorly controlled diabetes mellitus

• No NYHA class III-IV cardiac function

• No hepatitis B or hepatitis B carriers

• No other malignancy requiring treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior imatinib mesylate

• No prior interventional radiology for metastatic disease

• No other concurrent treatment, including surgery or radiotherapy, for metastatic lesions