Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have relapsed or refractory solid tumors of childhood. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
OBJECTIVES: I. Determine the response rate of patients with relapsed or refractory pediatric solid tumors treated with imatinib mesylate. II. Determine the toxicity of this drug in these patients. III. Determine the time to progression in patients treated with this drug. IV. Determine the pharmacokinetics of this drug in these patients. V. Correlate response with c-kit and platelet-derived growth factor receptor expression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/primitive neuroectodermal tumor vs osteosarcoma vs neuroblastoma vs other). Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Given orally
Correlative studies
Correlative studies
Children's Oncology Group
Arcadia, California, United States
Response rate, determined using the RECIST criteria
95% confidence interval will be computed.
Time frame: Up to 2 years
Toxicity reported using the CTC version 2.0
Time frame: Up to 2 years
Time to disease progression
Calculated by the method of Kaplan and Meier.
Time frame: Up to 2 years
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