A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma

Inclusion Criteria - Main cohort :

• Paediatric participants, aged >= 3 years and < 18 years
• Written informed consent obtained from the participant/parents or legally acceptable representative
• Newly diagnosed localised, supratentorial or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
• Local histological diagnosis confirmed by a designated central reference neuropathologist
• Availability of the baseline magnetic resonance imaging (MRI) performed according to imaging guidelines
• Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
• Adequate bone marrow, coagulation, liver, and renal function

Young Participant Cohort

• Written informed consent obtained from parents or legal representative
• Age at enrollment: from >= 6 months to < 3 years of age
• Progressive or relapsed metastatic or localised, supra- or infratentorial, non-brain stem WHO Grade III or IV glioma (local pathology confirmation made either at initial diagnosis or at relapse)
• Availability of a baseline MRI performed according to imaging guidelines
• Adequate organ function (bone marrow, coagulation, liver, kidney)

Exclusion Criteria - Main cohort:

• Metastatic HGG defined as evidence of neuraxis dissemination by MRI or positive cerebrospinal fluid (CSF) cytology
• WHO-defined Gliomatosis cerebri (multifocal HGG)
• Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
• Radiological evidence of surgically related intracranial bleeding
• Prior diagnosis of a malignancy and disease-free for 5 years
• Prior systemic anti-cancer therapy
• Previous cranial irradiation

Young Participant Cohort

• WHO-defined Gliomatosis cerebri (multifocal HGG)
• Newly diagnosed HGG below the age of 3 years
• Relapsed HGG below the age of 6 months or above the age of 3 years regardless of the age at first onset
• Indication for concomitant cranial irradiation, regardless of age
• Any disease or condition that contraindicates the use of the study medication/treatment or places the child at an unacceptable risk of experiencing treatment-related complications
• Any specific contraindication to MRI