NCT00030667

Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood

A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Childhood Desmoplastic Small Round Cell Tumor
• Childhood Synovial Sarcoma
• Gastrointestinal Stromal Tumor
• Lung Metastases
• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Neuroblastoma
• Recurrent Osteosarcoma

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2002-05-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2003-05-07
• Last updated: 2015-04-15

Locations

1 site across 1 country: United States