Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a specific type of brain tumour called glioblastoma (GBM) that has certain molecular features — specifically, MGMT promoter methylation and IDH wild type — confirmed by a laboratory test.
• People whose brain tumour has come back for the first time and whose medical team (including a specialist brain imaging doctor) has agreed the tumour has genuinely returned, rather than showing changes caused by previous treatment.
• People who previously had surgery for their first recurrence (without other treatments) and are now being considered for medication-based treatment for that recurrence.
• People who completed standard initial treatment with radiotherapy (at specific doses) plus a chemotherapy drug called temozolomide (TMZ), having received at least 3 cycles of TMZ after radiotherapy.
• People whose tumour showed at least stable disease (meaning it did not grow) at the end of their first-line treatment.
• People who are at least 3 months past day 28 of their last TMZ cycle.
• People who have a Karnofsky Performance Status score of 60 or above — a measure used by doctors to assess how well a person can carry out daily activities (confirm with trial site).
• People whose blood, kidney, and liver results fall within acceptable ranges when tested within the 14 days before joining the trial.
• People who had surgery for their recurrence where the surgical wound has healed well and where a brain scan shows remaining or new tumour activity suitable for treatment.
• People who have recovered from side effects of previous treatment to a mild level or better (Grade 2 or less).
• People taking steroid medications who have been on a stable or reducing dose for at least 7 days.
• People who are willing and able to give informed consent specifically for this trial.
• People who are willing and able to follow all trial requirements.
• People aged 16 or older.
• People who are able to begin treatment within 28 days of being enrolled in the trial.

Who may not be able to join:

• People whose tumour has certain molecular features that are inconsistent with IDH wild type GBM (for example, features of PXA or a BRAF mutation).
• People who have had another cancer (other than certain non-melanoma skin cancers) unless they have been cancer-free for at least one year.
• People who have previously received stereotactic radiotherapy, brachytherapy, or a specialist drug delivery procedure to the brain called Convection Enhanced Delivery (CED).
• People who have already received any treatment other than surgery for their first recurrence of GBM.
• People with an active health condition that the trial doctor believes would make trial treatment unsuitable for them.
• People with a personal history of schizophrenia, other psychotic illness, severe personality disorder, or another significant psychiatric diagnosis (not including depression related to their brain tumour condition).
• People who have previously had a serious allergic reaction or a severe side effect (Grade 3 or above) from temozolomide (TMZ).
• People who have used cannabis or cannabinoid-based medicines in the 28 days before enrolling, or who are unwilling to avoid these for the duration of the trial.
• Women who are pregnant, breastfeeding, or who are capable of becoming pregnant but are unwilling to use effective contraception during treatment and for 6 months after treatment ends — women of childbearing age must also have a negative pregnancy test within 7 days before enrolling.
• Men who are sexually active and unwilling or unable to use acceptable contraception during treatment and for 6 months after treatment ends.
• People who cannot have an MRI scan or who cannot receive the contrast dye (gadolinium) used in MRI.
• People with hereditary galactose intolerance, complete lactase deficiency, or a condition called glucose-galactose malabsorption.
• People with a known allergy to cannabinoids or to the other ingredients in the trial medication.
• People with a known history of current or past dependence on alcohol or drugs.
• People with a known infection with Hepatitis B, Cytomegalovirus (CMV), or certain other serious infections.
• People who have received a live vaccine within 28 days before enrolling.
• People who are unable to take medication applied to the inside of the mouth, due to mouth sores or other issues.
• People who are currently taking part in another clinical trial involving treatment.
• People facing psychological, family, social, or geographic circumstances that would make it difficult to follow the trial's requirements.

Important: Always verify eligibility with the trial site directly before applying.