Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083135
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2004-05-14
Brief Title:
N2000-01 Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory 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 Giving iodine I 131 metaiodobenzylguanidine 131I-MIBG may kill neuroblastoma cells by delivering radiation directly to the tumor A stem cell transplant using the patients stem cells may be able to replace blood-forming cells destroyed by radiation therapy
PURPOSE This phase I trial is studying the side effects and best dose of a double infusion of 131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of a double infusion of 131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine 131I-MIBG followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma
Determine the number of days after stem cell transplantation to achieve absolute neutrophil count 500mm3 for 3 days and platelet count 20000mm3 for 3 days without transfusions in patients treated with this regimen
Secondary
Determine the response rate in patients treated with this regimen based on lesions measurable by CT or MRI at study entry patients with 131I-MIBG scan-positive lesions only and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology
Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen
Correlate if possible TP53 mutations with response in patients with accessible bone marrow tumor treated with 131I-MIBG
OUTLINE This is a dose-escalation multicenter study
Iodine I 131 metaiodobenzylguanidine 131I-MIBG therapy Patients receive131I-MIBG IV over 2 hours on days 0 and 14
Cohorts of 3-6 patients receive escalating doses of 131I-MIBG 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
Stem cell transplantation therapy Patients undergo autologous peripheral blood stem cell transplantation on day 28 Patients receive filgrastim G-CSF IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 9-18 patients will be accrued for this study within 2 years
Primary
Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine 131I-MIBG followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma
Determine the number of days after stem cell transplantation to achieve absolute neutrophil count 500mm3 for 3 days and platelet count 20000mm3 for 3 days without transfusions in patients treated with this regimen
Secondary
Determine the response rate in patients treated with this regimen based on lesions measurable by CT or MRI at study entry patients with 131I-MIBG scan-positive lesions only and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology
Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen
Correlate if possible TP53 mutations with response in patients with accessible bone marrow tumor treated with 131I-MIBG
OUTLINE This is a dose-escalation multicenter study
Iodine I 131 metaiodobenzylguanidine 131I-MIBG therapy Patients receive131I-MIBG IV over 2 hours on days 0 and 14
Cohorts of 3-6 patients receive escalating doses of 131I-MIBG 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
Stem cell transplantation therapy Patients undergo autologous peripheral blood stem cell transplantation on day 28 Patients receive filgrastim G-CSF IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover
Patients are followed every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 9-18 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| N2000-01 | OTHER | NANT Consortium | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |