Gastrointestinal Stromal Tumor Clinical Trial
Official title:
A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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