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 who are at least 18 years old at the time of screening.
• People who are able to understand the purpose and risks of the study and have signed a written consent form approved by the relevant review board.
• People who have a brain tumour called glioma (confirmed by biopsy and tissue analysis) that has already been treated with a prior dose of 186RNL, specifically Grade III or Grade IV glioma according to 2021 WHO classification standards.
• People who had their last dose of 186RNL at least 90 days before screening.
• People taking anti-seizure medication who have been on a stable dose without any seizures for at least two weeks before starting treatment.
• People taking steroid medications to reduce brain swelling who have been on a stable or reducing dose for at least two weeks, with no worsening of symptoms.
• People whose tumour size falls within the treatment range being studied in their specific group (confirm with trial site).
• People with a physical functioning level rated 0 to 2 on a standard medical scale (ECOG), meaning they can generally care for themselves; a rating of 3 may also be considered if both the lead doctor and treating doctor agree it is in the person's best interest.
• People with a life expectancy of at least 2 months.
• People with liver function test results within acceptable ranges (confirm specific values with trial site).
• People with kidney function test results within acceptable ranges (confirm specific values with trial site).
• People with blood count levels within acceptable ranges, including white blood cells, platelets, and haemoglobin (confirm specific values and any flexibility with trial site).
• Women who could become pregnant must have a negative blood pregnancy test at screening, and both men and women must agree to use effective contraception from the start of the study until 6 months after the last dose.
• People whose glioma has continued to grow or returned after standard treatments such as surgery, radiation, or chemotherapy, and who are planned to have a stereotactic biopsy as part of standard care.

Who may not be able to join:

• People who have evidence of active, acute bleeding in the brain or within the tumour on a scan (those with minor, resolving, or old bleeding changes may still be considered — confirm with trial site).
• People who are unable to have an MRI scan of the brain.
• People who have not sufficiently recovered from significant side effects of previous cancer treatments, investigational drugs, or other medications (certain side effects such as hair loss, anaemia, and low lymphocyte counts are exceptions — confirm with trial site).
• People who are pregnant or breastfeeding.
• People with serious ongoing illnesses that the treating doctor determines would affect safety, including: uncontrolled high blood pressure despite treatment; wounds, ulcers, or bone fractures that are not healing; significant heart rhythm problems affecting heart function; untreated underactive thyroid; uncontrolled infection; heart failure or unstable chest pain within the last 3 months; a heart attack, stroke, or mini-stroke within the last 6 months; or an active cancer other than glioma (excluding certain minor skin cancers or early-stage cervical changes).
• People with an inherited condition that causes abnormal bleeding or problems with blood clotting.
• People who have previously received certain types of radiation or cancer treatments within specific timeframes before the study, including: non-standard radiation to the target area; other brain radiation within 12 weeks of screening; certain systemic cancer therapies within 14 days or 5 half-lives (whichever is shorter); biological therapies such as antibodies or immune treatments within 21 days; certain chemotherapy agents within 14 to 42 days depending on the type; prior treatment with carmustine wafers placed in the brain; or participation in another investigational drug or device trial within 28 days of screening, or current active enrolment in such a trial.
• People whose tumour has spread to multiple areas of the brain or to the lining of the brain or spinal cord.
• People with psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
• People whose tumour is located in the lower part of the brain (infratentorial), unless the lead doctor and neurosurgeon agree the area has already been treated (confirm with trial site).

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