TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide

Inclusion Criteria: * Pediatric patients in need of temozolomide (all indications with 5-day treatment per 21- or 28-day cycle). * Male and female patients aged 1 to less than 18 years * Patients who have signed the informed consent or for which one, both parents or legal guardian (depending on local legislation) have signed the informed consent. * Patients having records of coverage by a health insurance * Life expectancy ≥ 3 months * Adequate haematological function: * haemoglobin ≥ 80 g/L (transfusion support authorized) * neutrophil count ≥ 1.0 x 10e9 cells/L * platelet count ≥ 100 x 10e9 cells/L (without transfusion support) * in case of bone marrow involvement: neutrophils ≥ 0.5 x 10e9 cells/L and platelets ≥75 x 10e9 cells/L * Adequate renal function: * Creatine clearance ≥ 60 mL/min.1.73m² according to the Schwartz formula \[1\] or its modified form \[2\] * Adequate hepatic function: * bilirubin ≤1.5 x ULN * AST and ALT ≤ 2.5 x ULN (AST, ALT 5xULN in case of liver metastases) * Lansky Score ≥ 70% Exclusion Criteria: * Patients who are co-administrated at day one with sodium valproate as it decreases the clearance of temozolomide * Patients with (naso)gastric tube administration of temozolomide during first cycle of treatment. * Patients already enrolled in studies investigating temozolomide or other investigational new drugs. * A post-menarche female with a positive blood/urine pregnancy test at inclusion. * Known contraindication or hypersensitivity to temozolomide or any chemically close substance