Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008424
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2001-01-06
Brief Title:
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
Status:
COMPLETED
Status Verified Date:
2014-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants
PURPOSE Phase I trial to study the effectiveness of irinotecan in treating children with refractory or advanced solid tumors who are receiving anticonvulsants
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants
Determine the dose-limiting toxicity of irinotecan in this patient population
Evaluate the pharmacokinetic behavior of this treatment regimen in these patients
Determine preliminarily the antitumor activity of this treatment regimen in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to type of concurrent anticonvulsant enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants
Patients receive irinotecan IV over 1 hour daily for 5 days Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for up to 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this study
Determine the maximum tolerated dose of irinotecan in children with refractory or advanced solid tumors receiving anticonvulsants
Determine the dose-limiting toxicity of irinotecan in this patient population
Evaluate the pharmacokinetic behavior of this treatment regimen in these patients
Determine preliminarily the antitumor activity of this treatment regimen in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to type of concurrent anticonvulsant enzyme activating anticonvulsants vs valproic acid vs other anticonvulsants
Patients receive irinotecan IV over 1 hour daily for 5 days Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for up to 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 3-25 patients will be accrued for this 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 |
|---|---|---|---|
| CDR0000068410 | OTHER | Clinicaltrialsgov | None |
| COG-P9871 | OTHER | None | None |
| POG-P9871 | OTHER | None | None |