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

Primary Purpose

Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Malignant Fibrous Histiocytoma of Bone focused on measuring 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

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Washington Hospital Center
  • Lutheran General Cancer Care Center
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Mayo Clinic Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
June 17, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031915
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2003
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee J. Helman, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0912
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021-6007
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19451433
Citation
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].
Results Reference
result

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

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