Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287976
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2006-02-06
Brief Title:
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 such as irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma
PURPOSE This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the biological activity of irinotecan hydrochloride when given on a prolonged schedule in terms of response rate and rate of early progression in young patients with refractory or recurrent hepatoblastoma
Secondary
Determine the duration of response in patients showing stable disease or an objective response partial or complete response to this drug
Determine the time to progression and overall survival of patients treated with this drug
Determine the rate of resectability in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo evaluation for tumor resectability after courses 2 3 or 4 Patients whose disease is considered resectable at any of these time points proceed to surgery
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the biological activity of irinotecan hydrochloride when given on a prolonged schedule in terms of response rate and rate of early progression in young patients with refractory or recurrent hepatoblastoma
Secondary
Determine the duration of response in patients showing stable disease or an objective response partial or complete response to this drug
Determine the time to progression and overall survival of patients treated with this drug
Determine the rate of resectability in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo evaluation for tumor resectability after courses 2 3 or 4 Patients whose disease is considered resectable at any of these time points proceed to surgery
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20589 | None | None | None |
| CCLG-LT-2003-01 | None | None | None |
| CCLG-IRINOTECAN | None | None | None |