Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 glioblastoma or gliosarcoma (a type of brain tumour) located in the upper part of the brain, confirmed by laboratory analysis of tumour tissue, and who have had surgery to remove most or all of the tumour (at least 85%) within the past 35 days.
• People whose tumour has a specific genetic characteristic called "unmethylated MGMT."
• People whose tumour does not have changes in genes called IDH1 or IDH2, confirmed by an approved laboratory test.
• People between 18 and 75 years of age.
• People who are in generally good physical health and able to carry out daily activities, as measured by standard health scoring tools (confirm with trial site).
• People who have not received chemotherapy or a bone marrow transplant before their brain tumour diagnosis, and who have not received any chemotherapy for this brain tumour (including a type of medicated wafer sometimes placed in the brain during surgery).
• People who have a life expectancy of at least 12 weeks.
• People for whom standard full-course radiation therapy (not a shortened course) is planned.
• People whose blood counts, liver function, and kidney function meet specific levels required by the trial, confirmed by blood tests taken within 2 weeks of starting treatment.
• People who, if taking steroid medication after surgery, are on a dose of 8mg of dexamethasone per day or less, and whose dose has been stable or decreasing for at least 7 days before joining.
• People who are able and willing to use contraception if there is any possibility of pregnancy.
• People who are willing and able to understand and sign an informed consent form.
• People who have had all surgical stitches or staples removed before registering for the trial.
• People who are considered clinically stable at the time of enrolment.
• People who have been assessed by a transplant doctor as a potential candidate for a procedure using their own stem cells, and who have been screened for substance use history (a management plan must be in place for anyone with a significant history of substance use).
• People with no signs of active infection at the time of enrolment.
• People for whom 10 tissue samples or a preserved tumour sample are available for laboratory testing.
• People who have tested negative for Hepatitis B, Hepatitis C, and HIV.

Who may not be able to join:

• People with a known medical or inherited condition that weakens the immune system, or any other serious medical condition that could affect safety in the trial.
• People with a known history of HIV.
• People who are pregnant or breastfeeding.
• People with significant lung disease or breathing problems, including active lung infection or low oxygen levels, or reduced lung capacity below a certain level (confirm with trial site for specific thresholds).
• People with a known diagnosis of heart failure with reduced heart pumping function, or who have had a heart attack or other serious heart event within the 6 months before joining.
• People with a known history of irregular heart rhythms, including atrial fibrillation or abnormally fast or slow heart rates.
• People who are unable to have MRI scans repeated, or who have an allergy or intolerance to the dye used in MRI scans.
• People with active illegal drug use or a diagnosis of alcoholism.
• People who have previously had another cancer, unless it was a non-melanoma skin cancer, or a very early-stage cancer of the cervix, bladder, prostate, or breast — and unless the person has been cancer-free or in remission for at least 2 years before joining.
• People with a mental health condition or reduced mental capacity that would prevent them from giving informed consent.
• People with a known history of Hepatitis B or C, or serious liver inflammation.

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