Pediatric malignant pontine gliomas MedDRA version: 12.1 Level: LLT Classification code 10006143 Term: Brain stem glioma
Conditions
Interventions
Trade Name: gemzar
Pharmaceutical Form: Powder and solvent for solution for infusion
Trade Name: ledertepa
Pharmaceutical Form: Intravenous infusion
Trade Name: toposin
Pharmaceutical Form: Concentr
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with newly diagnosed DIPG - Patients with newly diagnosed, unresectable grade II-IV pontine glioma. - Age between 3 years and 18 years - Willingness to perform a pregnancy test in females of child bearing age - Written informed consent Laboratory findings: - Platelet count = 100 x109/L (transfusion independent) - Peripheral absolute neutrophil count (ANC) = 1.0 x109/L - Adequate Liver Function defined as: o Direct bilirubin = 1.5 x upper limit of normal (ULN) for age o SGPT (ALAT) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pilocytic (grade 1) astrocytomas - Presence of diffuse leptomeningeal disease. - Patients having been pre-treated for DIPG - Performance status (Lansky or Karnofsky score) of 50% or less - Pregnant or breastfeeding - Other contra-indications for chemotherapy - Neurofibromatosis type I, because of the much better prognosis of this patient group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main study objective Feasibility of this treatment regimen in children with pontine gliomas. ;Secondary Objective: Secundary study objective Evaluation of treatment efficacy Exploratory study objectives 1. Evaluation of quality of life (QOL), measured using standardised questionnaires (PedsQl). 2. Evaluate the contribution of MRS, FDG-PET and MET-PET to MRI. 3. Tissue analysis on targets. 4. Proteomics in blood and cerebrospinal fluid;Primary end point(s): Feasibility of the treatment regimen. Morbidity: at least 80% of patients must be able to complete full treatment, excluding patients that do not complete treatment because of other reasons than toxicity, to entilitle this study as feasible Mortality: treatment related mortality must be less than 13%, to entitle this study as feasible. | — |
Countries
Netherlands
Outcome results
None listed