Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
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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
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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 |
OBJECTIVES:
- 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.
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 |


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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 |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma
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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
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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
PATIENT CHARACTERISTICS:
Age:
- 10 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- ALT and AST less than 2.5 times ULN
Renal:
- Creatinine less than 1.5 times ULN
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No hormonal birth control
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Other:
- At least 28 days since any prior systemic therapy

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
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 |
Study Chair: | Lee J. Helman, MD | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031915 |
Obsolete Identifiers: | NCT00029094 |
Other Study ID Numbers: |
CDR0000069239 NCI-02-C-0097 CCUM-2001-034 CPMC-IRB-14060 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | June 19, 2013 |
Last Verified: | October 2003 |
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 |
Sarcoma Osteosarcoma Histiocytoma Histiocytoma, Benign Fibrous Histiocytoma, Malignant Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |