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 newly diagnosed with a specific type of brain tumour called glioblastoma multiforme (GBM), Grade 4, confirmed by tissue or molecular testing, with a gene pattern called "IDH wildtype."
• People whose tumour testing shows a positive "MGMT promoter methylation" result, using standard testing methods at the treating hospital.
• People whose planned treatment includes a standard 6-week course of radiation therapy combined with, and followed by, a chemotherapy drug called temozolomide — or a shorter 3-week radiation course if that is what has been planned (for example, in older patients).
• People aged 18 years or older.
• People whose general health and ability to function meets a minimum threshold on a standard medical scoring scale called the Karnofsky Performance Status (KPS), with a score above 60 (confirm with trial site).
• People who have not previously received radiation treatment to the brain.
• People who did not have a diagnosis of dementia or any other neurodegenerative condition (such as Alzheimer's disease, Parkinson's disease, or Motor Neuron Disease) before their GBM diagnosis.
• People whose life expectancy is greater than 6 months.
• People who are able to have repeated brain MRI scans using a contrast dye called gadolinium.
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning well enough to safely receive standard chemoradiation treatment (specific blood count and organ function levels apply — confirm with trial site).
• People with a history of chronic hepatitis B virus (HBV) infection whose viral load is undetectable while on suppressive treatment, if that treatment is required.
• People who have had, or currently have, another cancer whose history or treatment is unlikely to interfere with this trial's safety or results.
• People who are willing and able to read and sign an informed consent form.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who have had an allergic reaction to G-CSF (a medicine called filgrastim) or to similar medicines.
• People with an uncontrolled illness that could affect white blood cell counts, such as a serious infection requiring intravenous antibiotics, or people who are known to have HIV, as this affects the immune cells being studied in the trial.
• People who are pregnant, as the chemotherapy and radiation used in this trial carry risks of harm to an unborn baby. People who are breastfeeding would also need to stop breastfeeding if treated with chemotherapy as part of this trial.
• People who are not able to complete repeated thinking and memory tests conducted in English or Spanish, as these tests are a key part of the study. People who have significant difficulty with language as a result of their GBM diagnosis are also not eligible (confirm with trial site if there are any questions about this).
• People who currently have, or have had within the 6 months before their GBM diagnosis, a blood clot in the lungs (pulmonary embolism) or legs (deep vein thrombosis) — these cases would need individual discussion with the lead trial doctor before a decision is made.
• People with certain blood or inherited conditions, including sickle cell disease or sickle cell trait, a condition called congenital neutropenia, or blood cancers such as leukaemia or myelodysplastic syndrome, due to a higher risk of serious side effects from G-CSF.
• People who require high doses of steroid medication (equivalent to 8mg or more of dexamethasone per day), or who are not expected to be able to reduce their steroid dose to 4mg of dexamethasone or less before starting chemoradiation.

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