Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486564
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2007-06-12
Brief Title:
Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
A Phase I Trial of Nifurtimox for Relapsed or Refractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2009-10
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:
There is currently no curative treatment for children with relapsedrefractory neuroblastoma and for these children the 5 year survival rate is 10 As such new therapeutic approaches are needed to treat these children This Phase 1 clinical trial is specifically designed to test the safety and toxicity of nifurtimox when given in combination with cyclophosphamide and topotecan for the treatment of relapsed andor refractory neuroblastoma Prior to study opening 3 pediatric patients with neuroblastoma have received nifurtimox in combination with this chemotherapy regimen and all have had significant measurable responses without undue toxicity These case reports as well as our in vitro and in vivo investigations into the biologic effect of nifurtimox on neuroblastoma cells has prompted the development of this Phase I study This Phase I study will involve a dose escalation trial of daily oral nifurtimox alone for one 21 day cycle of therapy followed by continuation of nifurtimox with the addition of standard doses of cyclophosphamide 5 days and topotecan 5 days for 3 additional 21 day cycles Our primary aim is to evaluate the safety of nifurtimox alone and in combination with these chemotherapy agents in multiply relapsedrefractory patients Our secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment response
Detailed Description:
None
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