A COMPREHENSIVE AND TARGETED THERAPY APPROACH IN PEDIATRIC MALIGNANT PONTINE GLIOMAS - Comprehensive and multitargeted therapy for malignant pontine gliomas

Active, not recruiting

• Conditions: Pediatric malignant pontine gliomas; MedDRA version: 12.1Level: LLTClassification code 10006143Term: Brain stem glioma

• Registration Number: EUCTR2009-016080-11-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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:
oDirect bilirubin = 1.5 x upper limit of normal (ULN) for age
oSGPT (ALAT) < 5 x upper limit of normal (ULN) for age.
-Adequate Renal Function Defined As:
oSerum creatinine = 1.5 x upper limit of normal (ULN) for age.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main study objective<br>Feasibility of this treatment regimen in children with pontine gliomas.<br><br>;Secondary Objective: Secundary study objective<br>Evaluation of treatment efficacy<br><br>Exploratory study objectives<br>1.Evaluation of quality of life (QOL), measured using standardised questionnaires (PedsQl).<br>2.Evaluate the contribution of MRS, FDG-PET and MET-PET to MRI. <br>3.Tissue analysis on targets.<br>4.Proteomics in blood and cerebrospinal fluid;Primary end point(s): Feasibility of the treatment regimen. <br>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<br>Mortality: treatment related mortality must be less than 13%, to entitle this study as feasible.