Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509353
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2007-07-30
Brief Title:
N2004-06 Irinotecan and Vincristine With 131I-MIBG Therapy for ResistantRelapsed High-Risk Neuroblastoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Irinotecan and Vincristine With 131I-MIBG Therapy for ResistantRelapsed High-Risk Neuroblastoma A Phase I Study
Status:
COMPLETED
Status Verified Date:
2023-11
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 Radioactive drugs such as iodine I 131 metaiodobenzylguanidine MIGB may carry radiation directly to tumor cells and not harm normal cells Drugs used in chemotherapy such as irinotecan and vincristine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving iodine I 131 MIGB together with irinotecan and vincristine may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma
Detailed Description:
OBJECTIVES
Primary
To determine the maximum tolerated dose MTD of iodine I 131 metaiodobenzylguanidine when given in combination with fixed-dose irinotecan hydrochloride and vincristine in young patients with refractory or relapsed high-risk neuroblastoma
To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when combined with fixed-dose irinotecan hydrochloride and vincristine
Secondary
To determine if there is a therapeutic response to this regimen
OUTLINE This is a multicenter dose-escalation study of iodine I 131 metaiodobenzylguanidine 131I-MIBG
Patients receive 131I-MIBG IV over 1½-2 hours on day 1 vincristine IV on days 0 and 7 and irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11 Treatment repeats every 56 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
Primary
To determine the maximum tolerated dose MTD of iodine I 131 metaiodobenzylguanidine when given in combination with fixed-dose irinotecan hydrochloride and vincristine in young patients with refractory or relapsed high-risk neuroblastoma
To determine the dose-limiting toxicities of iodine I 131 metaiodobenzylguanidine when combined with fixed-dose irinotecan hydrochloride and vincristine
Secondary
To determine if there is a therapeutic response to this regimen
OUTLINE This is a multicenter dose-escalation study of iodine I 131 metaiodobenzylguanidine 131I-MIBG
Patients receive 131I-MIBG IV over 1½-2 hours on day 1 vincristine IV on days 0 and 7 and irinotecan hydrochloride IV over 1 hour on days 0-4 and 7-11 Treatment repeats every 56 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NANT-Draximage-2007-01 | OTHER | Draximage | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |
| N2004-06 | OTHER | None | None |