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Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
This study has been completed.
Study NCT00031915   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: October 16, 2009   History of Changes

March 8, 2002
October 16, 2009
June 2002
 
 
 
Complete list of historical versions of study NCT00031915 on ClinicalTrials.gov Archive Site
 
 
 
Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma
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

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Childhood Malignant Fibrous Histiocytoma of Bone
  • Sarcoma
Drug: imatinib mesylate
 
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. Epub 2009 May 18. Erratum in: J Clin Oncol. 2009 Sep 20;27(27):4630. Myers, Paul A [corrected to Meyers, Paul A].

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00031915
 
CDR0000069239, NCI-02-C-0097, CCUM-2001-034, CPMC-IRB-14060
National Cancer Institute (NCI)
 
Study Chair: Lee J. Helman, MD NCI - Pediatric Oncology Branch
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP