A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate, determined using the RECIST criteria
95% confidence interval will be computed.
Up to 2 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|