TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma

Inclusion Criteria

• •Ability to understand and sign the informed consent document
• •Men or women ≥18 years and ≤70 years
• •Newly-diagnosed GB confirmed by biopsy or by resection in the 4-7 weeks before being registered in the trial.
• •Patients must have at least 15 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived).
• •Patients must have recovered from previous surgeries (time between surgery and inclusion in the study: 6 weeks).
• •Karnofsky Index ≥60%.
• •Adequate bone marrow reserve: haemoglobin ≥10 g/dL, WBC \>3,000/mcL, absolute neutrophil count (ANC) ≥1,500 cells/μL, platelets ≥100,000 cells/μL.
• •Adequate liver function: Bilirubin \<1.5 times the upper limit of normal (ULN); AST ≤2.5 x ULN
• •Creatinine clearance \>60 ml/min/1.73 m2.
• •The study treatment's effects on the development of the human foetus are not known. For this reason, women of childbearing age and men must agree to use a suitable birth control method (hormonal, barrier, abstinence or surgical sterilisation) before inclusion in the study, for the duration of the study and for at least 3 months after completing the trial treatment. The definition of an effective method of birth control is based on the judgement of the principal investigator or their designee. If a woman is pregnant or there is suspicion that she might be pregnant while participating in the study, she must inform the trial doctor immediately. All women of childbearing age should have a negative pregnancy test (serum/urine) in the 2 weeks prior to the beginning of treatment.
• •Any patient with a history of significant cardiovascular disease, even if it is currently controlled, or who presents signs or symptoms that suggest impaired left ventricular function according to the investigator should have an assessment of left ventricular ejection fraction (LVEF) by ECCO or MUGA. If the LVEF in these circumstances is below the site's lower limit of normality or less than 50%, the patient will not be eligible.