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 aged 18 to 75 years old.
• People who have a laboratory-confirmed diagnosis of high-grade glioma (a type of brain tumour) that has come back or grown for the first or second time.
• People whose brain tumour is either able to be surgically removed or not able to be surgically removed.
• People whose tumour is visible and measurable on a specific type of brain scan (MRI), meeting certain size requirements.
• People whose last dose of the chemotherapy drug temozolomide was at least 4 weeks before surgery.
• People who have previously had radiation therapy, provided that the return of the tumour has been confirmed according to recognised medical guidelines, either through a biopsy or a specific type of MRI scan (confirm with trial site for full details on timing requirements).
• People whose blood sample shows the presence of a specific biological marker called DGM7.
• People whose blood test results show that their blood cell counts, liver function, and kidney function are within acceptable ranges as determined by the trial (confirm with trial site for specific values).
• People who are not pregnant at the time of joining or during the study, and who are willing to use at least one effective method of contraception in addition to barrier methods (such as condoms) from the time of signing the consent form until at least 12 months after the last dose of the study treatment, or until the treatment is no longer detectable in the blood, whichever takes longer.
• People who score 70 or above on a standard scale (called the Karnofsky Performance Score) that measures general health and ability to carry out daily activities.
• People who are able to give informed consent and follow the requirements of the study.

Who may not be able to join:

• People who have had another active cancer (other than certain minor skin cancers, a non-invasive cervical condition, or localised prostate cancer) within the past 5 years.
• People whose tumour has spread to multiple areas of the brain in a way that prevents the required biopsy or treatment procedure, or people whose tumour has come back three or more times inside the brain.
• People whose tumour has been confirmed by laboratory testing to be a specific type called oligodendroglioma or mixed glioma.
• People who have a history of HIV infection or other serious conditions that severely weaken the immune system.
• People whose kidney function is below a certain level (eGFR less than 50 cc/min) as measured by a blood test.
• People whose bone marrow function is impaired — for example, due to a blood disease, or because they are receiving or have received within the past month treatments (radiation or certain drugs) that suppress bone marrow.
• People who plan to receive, or have received within the past 30 days, a specific type of chemotherapy implant called a Gliadel® wafer during brain surgery.
• People who have an allergy to a medication called 5-FC (flucytosine).
• People who have a digestive condition that prevents them from absorbing oral medications such as 5-FC.
• People who are pregnant or currently breastfeeding.
• People who have recently used a medication called cytosine arabinoside within the past 3 weeks.
• People who have recently been treated with a medication called bevacizumab within the past 3 weeks.
• People who have recently been treated with temozolomide within the past 4 weeks.
• People with a history of abnormal bleeding, or who are currently taking blood-thinning medications or anti-inflammatory drugs (including NSAIDs) that cannot be safely stopped before surgery.
• People who have been dependent on high-dose steroid medication (dexamethasone above 8 mg per day) for a sustained period in the month before surgery.
• People with serious heart or lung conditions, or other significant medical or personal circumstances that, in the judgement of the trial doctors, would interfere with participation or compliance.
• People who have had an active infection requiring prescription antibiotic, antifungal, or antiviral treatment within the past 4 weeks.
• People who currently have or recently had an active COVID-19 infection confirmed by a specific type of test (qPCR).
• People who are not able to make their own informed decisions about participation.
• People who are currently taking part in another clinical trial or using an experimental medication or medical device within 4 weeks (or within 5 half-lives of the experimental medication, whichever is shorter) before joining.
• People who have any other medical or psychological condition that, in the trial doctors' assessment, could affect their ability to participate safely or comply with the study requirements.

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