Combination therapy for children with malignant pontine gliomas.
Recruiting
- Conditions
- Diffuse intrinsic pontine gliomaMalignant pontine glioma
- Registration Number
- NL-OMON28201
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
1. Newly diagnosed DIPG;
2. Newly diagnosed unresectable grade II-IV pontine glioma;
Exclusion Criteria
1. Pilocytic (grade 1) astrocytomas;
2. Presence of diffuse leptomeningeal disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase a: Tolerability of gemcitabine at 3 dose levels (toxicity according to CTCAE-4);<br /><br>Phase b: Tolerability of erlotinib and everolimus at two dose levels when added to bevacizumab-irinotecan (toxicity according to CTCAE-4);<br /><br>Phase c: Median overall survival.
- Secondary Outcome Measures
Name Time Method Phase a: Clinical response rate, response rate on MRI according to the WHO-criteria and the median progression free survival;<br /><br>Phase b: Median overall survival from time of progression;<br /><br>Phase c: Quality of life based on standardised questionairres.