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 years or older.
• People who have a malignant (cancerous) brain tumour confirmed by tissue testing and/or brain scans, classified as a high-grade tumour (WHO Grade 3 or 4), but not certain specific tumour types (Grade 3 ependymoma, medulloblastoma, or primary CNS lymphoma).
• People whose last radiation therapy to the brain was completed at least 3 months before the planned treatment in this trial.
• People whose last anti-cancer drug treatment was completed at least 1 month before the planned treatment in this trial.
• People whose tumour, as measured by MRI or CT scan within the 4 weeks before screening, is no larger than 250 cm³ in volume and less than 7 cm at its longest point.
• People who have at least one tumour area that can be measured and tracked using standard imaging guidelines (RECIST v1.1).
• People whose general physical functioning falls within an acceptable range on a standard medical scale (ECOG score of 2 or less), meaning they are able to carry out basic daily activities (confirm with trial site).
• People who, in the treating doctor's opinion, are expected to live for at least 3 more months.
• People whose blood counts and organ function (including liver and kidneys) meet specific minimum levels as determined by blood tests (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test at screening and again before the study drug is given; women who have been menopausal for more than 2 years or have had surgical sterilisation are not required to be tested.
• People who are able and willing to use two highly effective methods of contraception for at least 6 months after the trial treatment, if they or their partner could potentially conceive.
• People who are physically and mentally able to take part in the study and are willing to follow all study procedures.
• People who have read and signed an informed consent form agreeing to participate.

Who may not be able to join:

• People whose brain cancer has spread outside the skull, or who have tumours on both sides of the brain in multiple locations.
• People who have an active infection or another type of cancer that the treating doctor considers makes participation unsuitable.
• People whose tumour is considered treatable with standard surgery that is expected to be effective.
• People whose last radiation therapy to the brain was less than 3 months ago.
• People who had brain surgery (other than a drainage procedure or biopsy) less than 3 months ago, or who received chemotherapy less than 1 month ago.
• People who experienced severe side effects (Grade 3 or higher on a standard medical scale) from previous cancer treatments, not counting hair loss or certain nerve-related side effects.
• People who have received, or are expected to receive, any experimental drug, biological therapy, or medical device within 1 month before the planned treatment.
• People who are receiving or expected to receive certain drugs that affect blood vessel growth (except bevacizumab), or any live vaccines, within 1 month before the planned treatment.
• People who had major surgery within 1 month before the planned treatment, or who are still recovering from a previous surgery. Major surgery is defined as an operation requiring general anaesthesia and/or a hospital stay longer than 24 hours, with meaningful risk of complications (confirm with trial site).
• People who have previously experienced radiation damage to the spinal cord or radiation-caused tissue death in the brain or brain stem.
• People who the treating doctor considers to be at risk of blood vessel rupture during the trial (those who have had a stent implanted may still be considered, subject to the doctor's approval).
• People who have had serious heart failure, serious kidney failure, a heart attack, unstable chest pain, or poorly controlled irregular heartbeat within the 6 months before the planned treatment.
• People with severe ongoing health conditions that are poorly controlled, including but not limited to epilepsy, diabetes, high blood pressure, serious lung diseases, serious kidney diseases, significant heart failure (NYHA Class III or IV), phenylketonuria, or other serious conditions as judged by the treating doctor.
• People with a known or suspected allergy or sensitivity to boron, any ingredient in the study drug, or contrast dye used in scans.
• People with a condition called hereditary fructose intolerance.
• People who have a cardiac pacemaker, or anything that would interfere with the MRI or CT scans needed for treatment planning or monitoring.
• People who are unable to remain still lying down or seated in a body cast for more than 30 minutes.
• People with any medical or mental health condition that the treating doctor believes could affect safe or effective participation in the study.
• Women who are pregnant, planning to become pregnant, or breastfeeding during the study period.
• People who the treating doctor considers generally unsuitable for participation.
• People who have previously received boron neutron capture therapy (BNCT).

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