Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093353
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2004-10-06
Brief Title:
N2003-01 Irinotecan Temozolomide and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
A Phase I Study Of Oral Irinotecan Temozolomide Cefixime In Children With RecurrentResistant High-Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2009-05
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 such as irinotecan and temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of oral irinotecan when administered with fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant high-risk neuroblastoma
Determine the toxic effects of this regimen in these patients
Secondary
Determine the response rate in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate UGT1A1 genotype with the occurrence of dose-limiting diarrhea in patients treated with this regimen
Correlate BCRP genotype with pharmacokinetic phenotype in patients treated with this regimen
Correlate p53 status in tumor cells with response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of irinotecan
Patients receive oral cefixime once daily beginning 5 days before the start of fixed-dose temozolomide and irinotecan and continuing for the duration of the study Patients also receive oral temozolomide once daily on days 1-5 and oral irinotecan once daily on days 1-5 and 8-12 Courses repeat 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 determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A maximum of 12 patients are treated at the MTD
Patients are followed for toxicity response and survival
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 125 years
Primary
Determine the maximum tolerated dose of oral irinotecan when administered with fixed-dose temozolomide and cefixime in pediatric patients with recurrent or resistant high-risk neuroblastoma
Determine the toxic effects of this regimen in these patients
Secondary
Determine the response rate in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Correlate UGT1A1 genotype with the occurrence of dose-limiting diarrhea in patients treated with this regimen
Correlate BCRP genotype with pharmacokinetic phenotype in patients treated with this regimen
Correlate p53 status in tumor cells with response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of irinotecan
Patients receive oral cefixime once daily beginning 5 days before the start of fixed-dose temozolomide and irinotecan and continuing for the duration of the study Patients also receive oral temozolomide once daily on days 1-5 and oral irinotecan once daily on days 1-5 and 8-12 Courses repeat 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 determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A maximum of 12 patients are treated at the MTD
Patients are followed for toxicity response and survival
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 125 years
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 |
|---|---|---|---|
| N2003-01 | OTHER | NANT Consortium | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |