Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004078
Status:
COMPLETED
Last Update Posted:
2013-06-14
First Post:
1999-12-10
Brief Title:
Irinotecan in Treating Children With Refractory Solid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the efficacy of irinotecan in children with refractory CNS or solid tumors
II Assess the toxicity pharmacokinetics and pharmacodynamics of this regimen in this patient population
III Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients
OUTLINE Patients are stratified according to type of solid tumor EwingsPNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors or brain tumor medulloblastomaPNET vs brain stem glioma vs ependymoma vs other CNS tumors
Patients receive irinotecan IV over 60 minutes on days 1-5 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study
I Determine the efficacy of irinotecan in children with refractory CNS or solid tumors
II Assess the toxicity pharmacokinetics and pharmacodynamics of this regimen in this patient population
III Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients
OUTLINE Patients are stratified according to type of solid tumor EwingsPNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors or brain tumor medulloblastomaPNET vs brain stem glioma vs ependymoma vs other CNS tumors
Patients receive irinotecan IV over 60 minutes on days 1-5 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study
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 | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2012-02310 | REGISTRY | None | None |
| CDR0000067288 | OTHER | None | None |
| POG-9761 | OTHER | None | None |
| CCG-P9761 | OTHER | None | None |
| COG-P9761 | OTHER | None | None |