Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030667
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2002-02-14
Brief Title:
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Gleevec Imatinib Mesylate NSC 716051 Formerly STI571 in Children With Refractory or Relapsed Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Ewings sarcomaprimitive 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
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 Ewings sarcomaprimitive 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-01869 | REGISTRY | None | None |
| CDR0000069187 | None | None | None |
| COG-ADVL0122 | None | None | None |
| ADVL0122 | OTHER | None | None |
| ADVL0122 | OTHER | None | None |