Status:
COMPLETED
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Lead Sponsor:
Pfizer
Conditions:
Glioma
Medulloblastoma
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment approaches have failed; biopsy is not required for recurrent disease.
- Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization \[WHO\] grade 3 or 4)
- Life expectancy ≥ 3 months
Exclusion
- Diagnosis of brainstem glioma
- Concurrent administration of any other anti-tumor therapy
- Pre-existing uncontrolled diarrhea
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00404495
Start Date
April 1 2007
End Date
December 1 2011
Last Update
April 18 2012
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
2
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
3
Pfizer Investigational Site
Parkville, Victoria, Australia, 3052
4
Pfizer Investigational Site
Ghent, Belgium, 9000