Diffuse intrinsic pontine glioma Malignant pontine glioma
Conditions
Interventions
At diagnosis: If informed consent is obtained, a biopsy will be performed.
Phase a (after diagnosis):
Cohorts of 3 patients will receive local radiotherapy (54Gy) with 3 escalating dose levels of g
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed DIPG; 2. Newly diagnosed unresectable grade II-IV pontine glioma; 3. Age between 3 years and 18 years; 4. Willingness to perform a pregnancy test in females of child bearing age; 5. Written informed consent; 6. Platelet count ≥ 75 x109/L (transfusion independent); 7. Peripheral absolute neutrophil count (ANC) ≥ 0,75 x109/L; 8. Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; 9. SGPT (ALAT) < 5 x upper limit of normal (ULN) for age; 10. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for age; 11. Performance status (Lansky or Karnofsky score) ≥ 40%.
Exclusion criteria
Exclusion criteria: 1. Pilocytic (grade 1) astrocytomas; 2. Presence of diffuse leptomeningeal disease; 3. Patients having been pre-treated for DIPG; 4. Pregnant or breastfeeding; 5. Other contra-indications for chemotherapy; 6. Clinically no neurofibromatosis type 1 (NF-1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase a: Tolerability of gemcitabine at 3 dose levels (toxicity according to CTCAE-4); Phase b: Tolerability of erlotinib and everolimus at two dose levels when added to bevacizumab-irinotecan (toxicity according to CTCAE-4); Phase c: Median overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase a: Clinical response rate, response rate on MRI according to the WHO-criteria and the median progression free survival; Phase b: Median overall survival from time of progression; Phase c: Quality of life based on standardised questionairres. | — |
Contacts
Public ContactMarc Jansen
Postbus 7057
Outcome results
None listed