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

This study has been completed.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
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
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.

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 Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Intervention  Drug: imatinib mesylate
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  June 2002
Completion Date
Eligibility 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
Gender Both
Ages 10 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00031915
Organization ID CDR0000069239
Secondary IDs †† NCI-02-C-0097, CCUM-2001-034, CPMC-IRB-14060
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Study Chair:     Lee J. Helman, MD     NCI - Pediatric Oncology Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2003
First Received Date  March 8, 2002
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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