At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 83 enrolled
Drug / intervention
Irinotecan +1 moredrug
Likely dose
Irinotecan 10 mgfrom 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.
Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.
In Brief
A Phase 2 clinical trial evaluating Irinotecan and Temozolomide for Glioma and Medulloblastoma. Completed, enrolled 83 participants across 29 sites in 8 countries.
Detailed Summary
This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma, Medulloblastoma
CountriesAustralia, Belgium, Denmark, France, Italy, Poland, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartApr 2007
Primary CompletionJan 2011
Study CompletionDec 2011
TodayJul 2026
First PostedNov 28, 2006
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.6 years ago
Interventions
Irinotecandrug
Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles
Temozolomidedrug
Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles