Early 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 have fully understood the study and have voluntarily signed a consent form agreeing to take part.
• People aged 18 to 80 years old.
• People whose general physical functioning is rated at a good to fully active level on a standard oncology scale (ECOG score of 0 or 1).
• People with a life expectancy of at least 3 months.
• People with a diagnosis of glioblastoma confirmed by tissue testing under the 2021 World Health Organization brain tumour classification system, and whose tumour has tested positive for certain proteins (CA IX or CA XII) either by tissue testing or a specific PET/CT scan.
• People whose glioblastoma has been confirmed by tissue testing to have come back after previous treatments.
• People who the trial doctor judges to be suitable for placement of a small device in the skull (called an Ommaya reservoir) used to deliver the study drug.
• People whose tumour removal cavity (the space left after surgery) measures between 2.5 and 25 cubic centimetres.
• People who have been on a stable or reducing dose of steroid medication (no more than 5 mg per day of dexamethasone or equivalent) for at least one week before starting the trial drug.
• People whose side effects from previous cancer treatments have largely resolved to a mild level or better (Grade 1 or less), not counting hair loss.
• People whose blood, liver, kidney, and clotting test results meet specific minimum health thresholds set by the trial (confirm exact values with trial site).
• People who are able to have children, and their partners, who agree to use effective contraception throughout treatment and for 6 months after the last dose of the study drug.

Who may not be able to join:

• People who have received cancer treatments (such as radiotherapy, chemotherapy, biological therapy, or targeted therapy) within the 4 weeks before starting the trial, or within specific longer timeframes depending on the type of treatment (confirm exact timeframes with trial site).
• People who have taken part in another trial using an unapproved drug within the 4 weeks before starting.
• People who have had major surgery (not including needle biopsy) or a serious injury within 4 weeks before starting, or who are expected to need planned surgery during the trial.
• People with a known or suspected allergy to the study drug or similar substances.
• People who are unable to have contrast-enhanced MRI scans, for example due to a pacemaker or an allergy to contrast dye.
• People with an active or uncontrolled infection needing treatment through a drip, or who have an unexplained fever above 38.5°C during the screening period or before the first dose.
• People with serious blood clotting problems, a significant risk of bleeding, a history of gastrointestinal bleeding, or any moderate or severe bleeding event in the past 6 months.
• People with active Hepatitis B or active Hepatitis C, based on specific blood test results (confirm details with trial site).
• People with high blood pressure that remains uncontrolled despite standard treatment (readings of 160/100 mmHg or above).
• People with a history of serious heart conditions, including certain irregular heart rhythms, a prolonged heart electrical interval on ECG, a heart attack, heart failure, stroke, or other significant heart events within the past 6 months, or poor heart pumping function.
• People who have had another cancer that has not been cured within the past 3 years, except for certain early-stage cancers such as cervical carcinoma in situ or basal cell skin cancer.
• People who have two or more tumour spots in the brain, cancer that has spread outside the brain, or a tumour located in certain specific areas of the brain (the infratentorial compartment or basal ganglia).
• People whose brain MRI shows the tumour is growing into the walls of the brain's fluid-filled spaces (ventricles), or where the surgical cavity connects to those spaces.
• People with psychiatric conditions or who may have difficulty following the trial requirements.
• People who are pregnant or breastfeeding.
• People the trial doctor considers unsuitable for other medical reasons.

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