TEMOkids study: Study of the fate in the body, acceptability and safety study of KIMOZO, a drinkable form of temozolomide adapted to childre

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

• Paediatric patients already receiving commercially available temozolomide-based treatment or naïve paediatric patients requiring temozolomide-based treatment as per investigator’s decision (all indications with 5-day treatment per 21- or 28-day cycle). Indications include those described in the Temodal SmPC (i.e. malignant glioma such as glioblastoma and anaplastic astrocytoma). For patients having no therapeutic alternatives, the IMP may be used in off-label indications in accordance with current treatment protocols recommended by European and International Medical Associations (e.g. SIOPEN, EPSSG, COG, European ITCC, SIOP,…). Such indications include but are not limited to primarily neuroblastoma, medulloblastoma and also rhabdomyosarcoma, or Ewing sarcoma
• 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:
o haemoglobin = 80 g/L (transfusion support authorized)
o neutrophil count = 1.0 x 10e9 cells/L
o platelet count = 100 x 10e9 cells/L (without transfusion support)
o in case of bone marrow involvement: neutrophils = 0.5 x 10e9 cells/L and platelets =75 x 10e9 cells/L
• Adequate renal function:
o Creatine clearance = 60 mL/min.1.73m² according to the Schwartz formula [1] or its modified form [2]
• Adequate hepatic function:
o bilirubin =1.5 x ULN
o AST and ALT = 2.5 x ULN (AST, ALT 5xULN in case of liver metastases)
• Lansky Score = 70%
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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

• Patient treated with sodium valproate within two weeks prior to receiving Kimozo or Patients who are co-administrated on day one of Kimozo administration with sodium valproate as it decreases the clearance of temozolomide.
• Patients with (naso)gastric tube administration of temozolomide
• 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
•Persons who are living in a facility by order of a court or an administrative order.
•Patients infected by a SARS-CoV-2 variant.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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