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Status:

COMPLETED

Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Lead Sponsor:

Technical University of Munich

Conditions:

Gastrointestinal Stromal Tumor

Eligibility:

All Genders

18+ 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. Giving imatinib mesylate before surgery may shrink the tumor so that it can be r...

Detailed Description

OBJECTIVES: Primary * Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate. * Determine histolo...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00112632

    Start Date

    February 1 2005

    Last Update

    March 8 2012

    Active Locations (9)

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

    Page 1 of 3 (9 locations)

    1

    Allgemeines Krankenhaus - Universitatskliniken

    Vienna, Austria, A-1090

    2

    Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

    Berlin, Germany, D-13122

    3

    Universitaetsklinikum Bonn

    Bonn, Germany, D-53105

    4

    Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, Germany, D-50924