Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293319
Status:
COMPLETED
Last Update Posted:
2014-08-18
First Post:
2006-02-16
Brief Title:
131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
I-Metaiodobenzylguanidine I-MIBG Therapy for Refractory Neuroblastoma A Phase II Study
Status:
COMPLETED
Status Verified Date:
2014-08
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 131 I-MIBG may carry radiation directly to tumor cells and not harm normal cells
PURPOSE This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma
PURPOSE This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma
Determine the acute and late toxicity of this regimen in these patients
Secondary
Determine disease and symptom responses of patients treated with this regimen
OUTLINE This is a compassionate use study
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours Beginning 10 days later patients with low neutrophil counts receive filgrastim G-CSF subcutaneously until blood count recovers Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma
Determine the acute and late toxicity of this regimen in these patients
Secondary
Determine disease and symptom responses of patients treated with this regimen
OUTLINE This is a compassionate use study
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours Beginning 10 days later patients with low neutrophil counts receive filgrastim G-CSF subcutaneously until blood count recovers Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| UCSF-00161 | None | None | None |
| UCSF-05161 | None | None | None |