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

NCT00031915 | Completed Phase 2

• 4 other identifiers: CDR0000069239NCI-02-C-0097CCUM-2001-034CPMC-IRB-14060
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Interventions

imatinib mesylate DRUG

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (10)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0912, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021-6007, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• 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.

  PMID: 19451433 RESULT

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Fibrosarcoma; Liposarcoma; Hemangiosarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Adipose Tissue; Neoplasms, Vascular Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Lee J. Helman, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Study Completion: May 1, 2007
• Last Updated: June 19, 2013

Record last verified: 2003-10

Locations

US (10)