Phase 1 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 or older who are willing and able to sign a consent form
• People with a life expectancy of at least 12 weeks
• People who are willing and able to follow the trial schedule, including tests, procedures, and follow-up visits
• People who have a confirmed diagnosis of glioblastoma (a type of brain tumour) based on laboratory analysis of tissue, meeting specific 2021 classification standards
• People whose brain scans show the tumour has grown or come back, with the tumour measuring between 1 cm and 5 cm in at least two directions on an MRI scan with contrast dye
• People who have previously had surgery and treatment with a combination of radiation therapy and chemotherapy, with or without a device called Tumor Treating Fields (Optune®)
• People whose total radiation dose to the brain was less than 66 Gy
• People who have a general health and functioning level rated at 2 or below on the WHO performance scale (confirm with trial site)
• People who finished brain radiation therapy more than 6 months ago — or at least 12 weeks ago if there is tissue-confirmed evidence that the tumour has returned outside the previously treated area
• People who have waited long enough since their last cancer treatment before joining the trial, specifically: at least 4 weeks since temozolomide; at least 6 weeks since lomustine or similar drugs; at least 2 weeks since certain targeted therapy tablets; or at least 6 weeks since the last dose of bevacizumab or similar intravenous treatments
• People who, if taking steroid medications, have been on a stable or reducing dose equivalent to no more than 6 mg per day of dexamethasone for at least 7 days before registering
• People whose blood and organ function results fall within acceptable ranges when tested within 14 days before registering (including blood clotting, platelet count, kidney function, white blood cell count, and haemoglobin levels)
• Women of childbearing potential who have a negative pregnancy test within 14 days before registering
• Men, or women who are not pregnant — women of childbearing potential who are sexually active must be using or agree to use an accepted form of contraception
• People whose blood vessel anatomy allows a thin tube (microcatheter) to be safely placed in up to two locations to deliver the treatment to the tumour, as confirmed by the specialist medical team
• People whose tumour treatment volume is 150 cc or smaller, as determined by the medical team
• People whose tumour is located in various parts of the brain, including the non-dominant or dominant hemisphere, in either eloquent (areas linked to important functions like speech or movement) or non-eloquent regions — all four combinations are included in different groups within the trial (confirm with trial site)

Who may not be able to join:

• People whose tumour is present on both sides of the brain, located at the back of the brain (posterior fossa), involves deep brain structures such as the thalamus, brainstem, or internal capsule, is close to or growing into the brainstem or optic chiasm, has spread to the lining of the brain, or has spread outside the brain
• People who have had more than one course of external beam radiation therapy to the brain
• People who have received radiosurgery, brachytherapy, or short-course high-dose radiation therapy
• People who have had more than two different systemic (whole-body) treatment regimens, not counting maintenance temozolomide
• People who have previously received treatment delivered directly into the brain's arteries
• People who have had more than two surgical procedures related to their glioblastoma
• People who have previously received radiation therapy to the chest
• People considered by the medical team to be at higher risk of wound healing problems — for example, those who had brain surgery within the last 3 months, have poor skin condition, a previously infected surgical site, or any other condition raising infection risk
• People with epilepsy (seizures) that is not well controlled
• People with serious ongoing health conditions, including: severe high blood pressure not adequately controlled by medication; unstable or symptomatic heart disease, known right-to-left heart shunts, or severe high blood pressure in the lungs; low blood oxygen levels; an active bacterial or viral infection (including HIV) requiring treatment; lung inflammation (pneumonitis); a psychiatric illness or personal situation that would make it hard to follow the study requirements; any nerve damage rated grade 1 or above (confirm with trial site); or any other condition the treating doctor believes would affect safety or study results
• People who are currently pregnant or breastfeeding (unless they agree to stop breastfeeding)
• People who have had another active cancer diagnosis within the past year — exceptions include certain treated skin cancers or early-stage cancers with no current evidence of disease, or people whose only active cancer is the recurrent glioblastoma being studied
• People with a history of stroke caused by blocked blood vessels, or who are at risk of the brain shifting dangerously within the skull
• People who cannot have a contrast-enhanced MRI scan for medical reasons
• People with a known history of allergic reactions to iodine-based or gadolinium-based contrast dyes used in imaging
• People who have taken part in another experimental treatment within 4 weeks before the planned treatment date, or who are currently in or plan to join another experimental trial that could interfere with this one (unless written permission is given by the study sponsor)
• People whose blood vessel structure, abnormal connections between arteries and veins, or vessel shape makes it unsafe or not feasible to access the blood vessels needed for the procedure, as seen on imaging

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