A Phase II Study of Gleevec (Imatinib Mesylate, NSC 716051 Formerly STI571) in Children With Refractory or Relapsed Solid Tumors
Overview
- Phase
- Phase 2
- Intervention
- imatinib mesylate
- Conditions
- Childhood Desmoplastic Small Round Cell Tumor
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Toxicity reported using the CTC version 2.0
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed solid tumors including the following:
- •Ewing's sarcoma
- •Bone or soft tissue primitive neuroectodermal tumor
- •Osteosarcoma
- •Neuroblastoma
- •Desmoplastic small round cell tumor
- •Synovial cell sarcoma
- •Gastrointestinal stromal tumor (GIST)
- •Metastatic pulmonary disease eligible
- •No pleural effusion of any size or definite radiologic evidence of pleural-based disease
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (imatinib mesylate)
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.
Intervention: imatinib mesylate
Treatment (imatinib mesylate)
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.
Intervention: laboratory biomarker analysis
Treatment (imatinib mesylate)
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.
Intervention: pharmacological study
Outcomes
Primary Outcomes
Toxicity reported using the CTC version 2.0
Time Frame: Up to 2 years
Response rate, determined using the RECIST criteria
Time Frame: Up to 2 years
95% confidence interval will be computed.
Secondary Outcomes
- Time to disease progression(Up to 2 years)