At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 112 enrolled
Drug / intervention
Nifurtimox +2 moredrug
Likely dose
Nifurtimox 30mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma.
In Brief
A Phase 2 clinical trial evaluating Nifurtimox, Cyclophosphamide, and 1 other intervention for Neuroblastoma and Medulloblastoma. Completed, enrolled 112 participants across 15 sites.
Detailed Summary
The purpose of this study is to determine whether nifurtimox in combination with cyclophosphamide and topotecan are effective in the treatment of relapsed or refractory neuroblastoma and medulloblastoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma, Medulloblastoma
CountriesUnited States
CollaboratorsBayer
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionApr 2020
Study CompletionOct 2022
TodayJul 2026
First PostedJan 25, 2008
Enrollment StartJan 14, 2008
Primary CompletionApr 28, 2020
Study CompletionOct 28, 2022
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 18.4 years ago
Interventions
Nifurtimoxdrug
30mg/kg/day PO divided into TID dosing q day
Cyclophosphamidedrug
250 mg/m2/dose in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.
Topotecandrug
0.75mg/m2/dose, in normal saline, IV, infused over 30 minutes on days 1-5 of each cycle.