ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

Exclusion Criteria

• •Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
• •Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year.
• •Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.
• •Prior treatment, apart from debulking surgery, for first recurrence of GBM.
• •Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.
• •Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition.
• •Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment.
• •Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and/or unwilling to abstain for the duration of the trial.
• •Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment.
• •o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation.
• •Men who are sexually active and unwilling/unable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment.
• •Contra-indication to MRI or gadolinium.
• •Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• •Known hypersensitivity to cannabinoids or excipients of the IMP.
• •Known history of current or prior alcohol or drug dependence.
• •Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection.
• •Has received a live vaccine within 28 days prior to randomisation.
• •Unable to administer oromucosal medication due to mucosal lesions or other issues.
• •Participation in another therapeutic clinical trial whilst taking part in this trial.
• •Any psychological, familial, sociological or geographical condition hampering protocol compliance.