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Status:

COMPLETED

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

Lead Sponsor:

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborating Sponsors:

Niigata University Medical & Dental Hospital

Conditions:

Gastrointestinal Stromal Tumor

Metastatic Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE2

Brief 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 ...

Detailed Description

OBJECTIVES: * To evaluate the safety and efficacy of imatinib mesylate in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor. OUTLINE: This is a multicenter stud...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2016

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT00764595

    Start Date

    October 1 2008

    End Date

    March 1 2016

    Last Update

    July 21 2023

    Active Locations (36)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (36 locations)

    1

    Aichi Cancer Center

    Nagoya, Aichi-ken, Japan, 464-8681

    2

    Aichi Medical University

    Nagoya, Aichi-ken, Japan, 480-1195

    3

    Hirosaki University, School of Medicine

    Hirosaki, Aomori, Japan, 036-8562

    4

    National Hospital Organization Kure Medical Center

    Kure, Hiroshima, Japan, 737-0023