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

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00031915

First received: March 8, 2002

Last updated: October 16, 2009

Last verified: October 2003

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2002

Last Updated Date

October 16, 2009

Start Date ^ICMJE

June 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00031915 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma

Intervention ^ICMJE

Drug: imatinib mesylate

Study Arm (s)

Not Provided

Publications *

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00031915

Other Study ID Numbers ^ICMJE

CDR0000069239, NCI-02-C-0097, CCUM-2001-034, CPMC-IRB-14060

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Lee J. Helman, MD

National Cancer Institute (NCI)

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2003

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

To Top