Phase 2 Melanoma 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 have been diagnosed with melanoma that has spread (confirmed by tissue or cell testing), with tumours in the brain confirmed by imaging.
• People whose brain tumours are currently causing symptoms, or who need steroid medication to manage symptoms caused by the brain tumours.
• People whose brain tumours are suitable for a type of focused, high-dose radiation treatment — specifically, tumours that are 5mm or larger, causing symptoms, or located in sensitive areas of the brain.
• People whose general health and ability to carry out daily activities falls within a standard medical rating scale score of 0 to 2 (ranging from fully active to capable of limited self-care) (confirm with trial site).
• People who have at least one brain tumour that is causing symptoms.
• People whose blood test results meet specific thresholds for red blood cells, white blood cells, platelets, liver function, and kidney function (confirm with trial site for exact values).
• People aged 18 or older.
• People who are able to give written informed consent, attend the trial site for appointments, and cooperate with treatment and follow-up visits.

Who may not be able to join:

• People who have previously had radiation treatment to the brain.
• People who have had another active cancer requiring treatment within the last 2 years — though people who were treated for another cancer with the aim of cure and currently show no signs of that cancer may still be considered.
• People who have previously received systemic (whole-body) treatment for melanoma, unless that treatment was given before or after surgery for cancer outside the brain, finished more than 6 months before joining the trial, and was given at a time when imaging confirmed no brain tumours were present.
• People who are unable to have an MRI scan of the brain.
• People with a confirmed diagnosis of cancer spreading to the lining of the brain and spinal cord (leptomeningeal disease) — though people with uncertain findings may be considered after discussion with the lead investigator.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test before joining and must agree to use two forms of contraception, or abstain from sex, throughout the trial and for six months after any treatment. Abstinence is only accepted if it is consistent with the person's usual lifestyle; certain methods such as calendar-based or withdrawal methods are not accepted.
• Men whose partners could become pregnant, unless they agree to use a barrier method of contraception or abstain from sex from the first treatment with bevacizumab, throughout the trial and for six months afterwards — and also ensure their partner uses an effective contraception method for the same period. Men with pregnant or breastfeeding partners must use barrier contraception.
• People who have significant bleeding within a brain tumour — specifically, bleeding covering more than 50% of a tumour larger than 10mm (a specific type of MRI scan is required to assess this).
• People with any brain tumour larger than 5cm in diameter.
• People whose steroid dose has been increasing in the 48 hours before starting the trial treatment, or who are currently taking more than 8mg per day of dexamethasone (or an equivalent steroid).
• People who have had major chest or abdominal surgery within 28 days before starting trial treatment.
• People who have had brain surgery within 14 days before starting trial treatment.
• People with active or a history of serious autoimmune disease that requires ongoing systemic anti-inflammatory treatment — though people with well-controlled autoimmune conditions not requiring such treatment may be considered after discussion with the lead investigator. People with severe autoimmune lung disease are not eligible.
• People with a history of inflammatory bowel disease.
• People who currently need ongoing systemic medication to suppress the immune system (other than steroids).
• People who have had an inflammatory condition in the abdomen within the past 6 months, such as stomach ulcers, diverticular disease, or colitis.
• People who have had an abdominal or throat-to-oesophagus fistula, a hole in the gastrointestinal tract, or an abdominal abscess within the past 6 months.
• People who have experienced a bowel blockage, or shown signs of bowel obstruction, or who have needed intravenous fluids, feeding tubes, or nutritional support through a drip within the past 6 months.
• People who have had a serious bleeding or haemorrhage event (graded as severe or worse) within 28 days before starting trial treatment — though people whose bleeding brain tumour was treated with brain surgery may still be considered, subject to the rule about timing of brain surgery above.
• People who are currently taking full-dose blood-thinning or clot-dissolving medication within 10 days of starting the trial.
• People with a known condition affecting blood clotting or causing a tendency to bleed.
• People with poorly controlled high blood pressure (blood pressure at or above 160/100 mmHg despite maximum medication), or a history of hypertensive crisis or hypertensive brain injury.
• People with current heart failure, a history of significant heart disease (class III or IV on a standard heart disease scale), a history of reduced blood supply to the heart, or a history of abnormal heart rhythm.
• People who are currently taking part in another interventional clinical trial, or who plan to do so — though participation in an observational study (where no treatment is given) is acceptable.
• People who, in the investigator's opinion, would not be a suitable candidate for this trial for any other reason.

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