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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031915 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma
Eligible subtypes:
Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021-6007 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Lee J. Helman, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000069239, NCI-02-C-0097, CCUM-2001-034, CPMC-IRB-14060 |
| Study First Received: | March 8, 2002 |
| Last Updated: | October 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031915 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Histiocytoma, Malignant Fibrous Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Histiocytoma, Benign Fibrous Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Imatinib Neoplasms, Connective and Soft Tissue |
Neuroectodermal Tumors Neoplasms Histiocytoma Therapeutic Uses Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |