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NCT00486564 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma
A Phase 1 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00486564 is a Phase 1 study that has completed, run by University of Vermont. The registered enrollment target is 20 participants.
The verdict
NCT00486564, a Phase 1 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
There is currently no curative treatment for children with relapsed/refractory 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 and/or 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 relapsed/refractory patients. Our secondary aim will be to evaluate the pharmacokinetics of nifurtimox as well as treatment response.
Interventions
- DRUG Nifurtimox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00486564
The ClinicalTrials.gov registry entry for NCT00486564 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nifurtimox is the first listed.
NCT00486564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00486564 about?
NCT00486564 is a clinical study titled "Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma". There is currently no curative treatment for children with relapsed/refractory 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 ...
What is the current status of trial NCT00486564?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-11. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00486564?
The interventions under investigation include: Nifurtimox (DRUG).
Who is sponsoring clinical trial NCT00486564?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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