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

Study Timeline

• Last Update Posted: 28 February 2024

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.