Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311584
Status:
COMPLETED
Last Update Posted:
2014-09-30
First Post:
2006-04-05
Brief Title:
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Irinotecan Temozolomide in Children With Recurrent Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2014-09
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 such as irinotecan and temozolomide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma
PURPOSE This phase II trial is studying how well giving irinotecan together with temozolomide works in treating young patients with recurrent neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in pediatric patients with relapsed neuroblastoma NB treated with irinotecan hydrochloride and temozolomide
Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen
Secondary
Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy
Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients
Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies
Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis
Assess preliminarily the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis
OUTLINE This is a multicenter study
Patients are stratified according to disease status measurable disease measured by conventional CT scan andor MRI vs evaluable disease tumor detected by conventional morphologic analysis of bone marrow aspiratebiopsy ANDOR abnormal uptake at 1 site on MIBG scan
Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the response rate in pediatric patients with relapsed neuroblastoma NB treated with irinotecan hydrochloride and temozolomide
Determine the toxicities associated with irinotecan and temozolomide in patients treated with this regimen
Secondary
Evaluate the impact of p53 loss of function on response rate and event-free survival from start of relapse therapy
Collect data for ongoing analyses of UGT1A1 polymorphisms in these patients
Collect and bank serum and nucleic acid specimen to facilitate future biomarker studies
Evaluate the feasibility of collecting blood samples on a group wide basis for assessment of changes in circulating markers of angiogenesis
Assess preliminarily the effects of irinotecan hydrochloride and temozolomide on circulating markers of angiogenesis
OUTLINE This is a multicenter study
Patients are stratified according to disease status measurable disease measured by conventional CT scan andor MRI vs evaluable disease tumor detected by conventional morphologic analysis of bone marrow aspiratebiopsy ANDOR abnormal uptake at 1 site on MIBG scan
Patients receive irinotecan hydrochloride IV over 1 hour on days 1-5 and 8-12 and oral temozolomide on days 1-5 Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| COG-ANBL0421 | OTHER | Childrens Oncology Group | None |
| CDR0000465487 | OTHER | None | None |