Phase 1 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 are willing and able to give their consent, attend all study visits, and follow the study schedule
• People who have been diagnosed with a returning (recurrent) brain tumour — specifically glioblastoma (GBM), gliosarcoma, a certain type of anaplastic astrocytoma with a normal IDH-1 gene, or a grade 4 astrocytoma with a mutated IDH gene — and whose tumour shows up clearly on MRI scans measuring between 1.0 cm and 5.0 cm
• People whose MRI scan clearly shows the tumour has come back or grown after previous surgery, chemotherapy, or radiation, with that MRI taken within 24 days before joining the study
• People aged 18 years or older
• People whose blood vessel test (Doppler study) shows less than 50% blockage in a key neck artery (the internal carotid artery), meaning a specific treatment procedure is considered safe to carry out
• People whose tumour can be surgically removed at the time of the study assessment, if they are enrolled in the part of the study that involves surgery
• People who score 70 or above on a standard scale that measures how well a person can carry out daily activities (Karnofsky performance score)
• People who are expected to live for at least 16 weeks
• People with healthy enough blood counts, liver function, and kidney function, confirmed by blood tests, before starting treatment
• People whose blood clotting test results are within an acceptable range (no more than 1.5 times the upper limit of normal)
• People who have finished previous chemotherapy treatments within required time periods before the study start date, and have recovered from any side effects to a mild level or better
• People who are at least 8 weeks past their last radiation treatment (or 4 weeks if a new tumour area outside the original radiation zone has appeared, or sooner if a biopsy has confirmed the tumour has returned)
• People who are willing to avoid other cancer treatments — chemotherapy, other drugs, or radiation — while taking part in the study
• Women who could become pregnant must have a negative pregnancy test at the screening visit
• People (and their partners) who are willing to use effective contraception during the study and for up to 6 months after receiving the study treatment (confirm with trial site for approved methods)

Who may not be able to join:

• People whose brain tumour is a different type than those listed above
• People whose tumour is located in the lower back part of the brain (posterior fossa or below the tentorium), or has spread beyond the skull
• People whose tumour has spread along the surface lining of the brain or spinal cord (leptomeningeal spread)
• People for whom getting access to a blood vessel for the procedure would be difficult
• People with more than 50% blockage in the carotid artery on the same side as the tumour, confirmed by Doppler studies
• People with blood clotting disorders or other blood diseases
• People who have received blood transfusions or certain blood-stimulating medications within 28 days before the study start date
• People who have had biological or immunotherapy treatments within 2 weeks before the study start date
• People with signs of inflammatory or autoimmune conditions, based on clinical or lab findings
• People who cannot have an MRI scan — for example, those with pacemakers, certain metal implants, surgical clips, or metallic objects in the eyes
• Women who are pregnant or breastfeeding
• People with signs of an active, uncontrolled infection, or serious unstable medical conditions, or who have a fever of 38°C or above
• People whose medical condition makes surgery or the endovascular procedure unsafe
• People with a history of alcohol or substance dependency in the past 12 months that has caused health problems
• People with a weakened immune system, autoimmune conditions, active hepatitis, or HIV
• People who are taking blood-thinning medications or other medications that increase bleeding risk that cannot be safely stopped before surgery (confirm with trial site, as some exceptions may apply)
• People whose medical or psychological history, in the investigator's opinion, may interfere with their ability to safely take part or give informed consent
• People with certain other brain or nervous system conditions such as encephalitis or multiple sclerosis
• People with a known inherited condition called Li-Fraumeni Syndrome, or a known inherited fault in the retinoblastoma gene or related pathways
• People with serious ongoing health conditions such as heart failure, history of strokes, kidney failure, active liver disease, organ transplant history, or significant psychiatric conditions
• People who are already enrolled in another treatment clinical trial
• People who have any condition that would prevent them from following the study requirements
• For people enrolled in the surgical part of the study: people where the surgeon believes there is a high chance the study injection would enter the brain's fluid-filled spaces (ventricles) after tumour removal

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