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

• ClinicalTrials.gov Identifier: NCT00031915
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: June 19, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Study Description

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:

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 Design

• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

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

Criteria

DISEASE CHARACTERISTICS:

• 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

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

Contacts and Locations

Locations

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)

Investigators

• Study Chair: Lee J. Helman, MD; National Cancer Institute (NCI)

More Information

Publications of Results:

Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18. Erratum in: J Clin Oncol. 2009 Sep 20;27(27):4630. Myers, Paul A [corrected to Meyers, Paul A].

• ClinicalTrials.gov Identifier: NCT00031915 History of Changes
• Obsolete Identifiers: NCT00029094
• Other Study ID Numbers: CDR0000069239; NCI-02-C-0097; CCUM-2001-034; CPMC-IRB-14060
• First Posted: January 27, 2003
• 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:

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