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:

• Adults aged 18 or older at the time of joining the study
• People who have been newly diagnosed with a specific, high-grade brain tumour (called glioblastoma, or GBM, WHO grade 4, IDH wildtype, MGMT unmethylated) that still shows some visible disease on a brain scan after initial treatment, and where the contrast-enhancing part of the tumour is no larger than 3 cm across in any direction
• People who have completed the standard course of radiation therapy and chemotherapy (a drug called temozolomide, or TMZ), followed by 2 additional cycles of TMZ after radiation — noting that people whose tumour was known to be MGMT unmethylated before starting radiation may not have been required to take TMZ alongside radiation
• People with a Karnofsky Performance Score above 70%, meaning they are reasonably functional in daily life (confirm with trial site)
• People who are able to have a brain MRI scan with and without contrast dye
• People whose blood test results before catheter placement meet specific thresholds, including: haemoglobin of at least 9 g/dL; platelet count of at least 100,000/µL (and at least 125,000/µL at the time of catheter insertion, which may be reached with a platelet transfusion); neutrophil count of at least 1,000; kidney function (creatinine) within 1.5 times the normal range; liver values (bilirubin, AST, ALT) within acceptable ranges as defined by the trial
• People whose blood clotting results (PT and PTT) are within 1.2 times the normal range before the procedure — people on blood thinners for a previous clot history may still be considered, provided anticoagulation is paused around the procedure as directed by the surgical team; for those on warfarin, an INR below 2.0 is required
• People who either cannot become pregnant (due to age, surgical history, or not being sexually active) or who agree to use an approved form of contraception during the trial — this applies to the participant or their partner(s)
• People who are able to read, understand, and sign an informed consent form approved by the ethics review board

Who may not be able to join:

• People who are pregnant or currently breastfeeding or chestfeeding
• People who have a life-threatening condition where the brain is at immediate risk of dangerous swelling or shifting, as assessed by the study neurosurgeons
• People with serious active health conditions, including: an active infection currently being treated with intravenous antibiotics, or an unexplained fever; a known disease or condition that weakens the immune system; severe heart disease (classified as New York Heart Association Class 3 or 4); significant lung disease (FEV1 below 50%); uncontrolled diabetes; a known allergy to albumin; known HIV or Hepatitis C infection; or a major medical illness or psychiatric condition that the trial investigators believe would prevent safe completion of the treatment
• People who have previously received any other treatment for their newly diagnosed GBM beyond surgical removal, standard radiation with TMZ, and the 2 post-radiation cycles of TMZ
• People who finished their combined radiation and TMZ treatment fewer than 11 weeks before the planned start of the trial infusion
• People whose tumour is located in the brainstem, cerebellum, or spinal cord, or whose scans show actively growing tumour in multiple locations, tumour crossing the midline of the brain, widespread disease along the brain's inner lining, or spread to the fluid surrounding the brain and spinal cord
• People taking more than 4 mg per day of the steroid dexamethasone within the 2 weeks before the trial infusion is due to start
• People with a worsening steroid-related muscle condition causing progressive weakness in the upper arms and legs
• People who currently require active treatment for an unrelated cancer, with the exception of certain early-stage or skin cancers (cervical carcinoma in situ, or adequately treated basal cell or squamous cell skin cancer)
• People with an active autoimmune disease that has required immune-suppressing medication within the past 3 months
• People who are unable to have an MRI scan due to body size or because they have certain metal devices in their body (such as a pacemaker, infusion pump, metal aneurysm clips, metal joint replacements, rods, or plates), or people with a known severe allergy to MRI contrast dye — noting that people with mild allergies such as a rash only may still be considered and would receive pre-treatment medication beforehand

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