Trials / Completed
CompletedNCT00404495
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irinotecan | Irinotecan 10 mg/m\^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles |
| DRUG | Temozolomide | Temozolomide 100-125 mg/m\^2 daily on days 1-5 in repeated 3 week cycles |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-01-01
- Completion
- 2011-12-01
- First posted
- 2006-11-28
- Last updated
- 2012-04-18
- Results posted
- 2012-02-17
Locations
29 sites across 8 countries: Australia, Belgium, Denmark, France, Italy, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00404495. Inclusion in this directory is not an endorsement.