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Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00031915
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.

Condition or disease Intervention/treatment Phase
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma Drug: imatinib mesylate Phase 2

Detailed Description:


  • Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens.
  • Determine the clinical and laboratory toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype.

Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Gleevec (Formerly Known as STI571) in Patients With Soft Tissue and Bone Sarcomas: A Multi-Disciplinary Trial of the North American Sarcoma Study Group of the Connective Tissue Oncology Society
Study Start Date : June 2002
Actual Study Completion Date : May 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma

    • Eligible subtypes:

      • Ewing's family (e.g., primitive neuroectodermal tumor)
      • Osteosarcoma
      • Synovial sarcoma
      • Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)
      • Liposarcoma (all variants)
      • Malignant fibrous histiocytoma
      • Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma)
      • Fibrosarcoma
      • Angiosarcoma (all variants)
    • Failed standard therapy with no available salvage regimens
  • Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination

    • Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy



  • 10 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • ALT and AST less than 2.5 times ULN


  • Creatinine less than 1.5 times ULN


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No hormonal birth control


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered


  • Not specified


  • At least 28 days since any prior systemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031915

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021-6007
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Lee J. Helman, MD National Cancer Institute (NCI)
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00031915    
Obsolete Identifiers: NCT00029094
Other Study ID Numbers: CDR0000069239
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: October 2003
Keywords provided by National Cancer Institute (NCI):
metastatic osteosarcoma
recurrent childhood rhabdomyosarcoma
recurrent osteosarcoma
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
pleomorphic childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
childhood fibrosarcoma
childhood synovial sarcoma
childhood liposarcoma
childhood alveolar soft-part sarcoma
childhood neurofibrosarcoma
childhood angiosarcoma
childhood malignant fibrous histiocytoma of bone
previously treated childhood rhabdomyosarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
fibrosarcomatous osteosarcoma
Additional relevant MeSH terms:
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Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action