Phase 2 Melanoma 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 a solid cancer (confirmed by biopsy) that has spread to the brain, with at least one brain tumour measuring 5mm or larger on a scan.
• The brain tumour(s) must fall into at least one of these categories: melanoma that has continued growing in the brain despite immunotherapy; a cancer that started in the digestive system (such as the bowel, stomach, or colon); HER2-positive breast cancer; cystic (fluid-filled) brain metastases; brain metastases measuring 2cm or larger; brain metastases that have come back after previous targeted radiation to the brain; or brain metastases that have come back after previous whole-brain radiation.
• People aged 18 or older at the time their brain metastases were diagnosed.
• People whose kidneys are functioning at a sufficient level, based on a blood test result of at least 60 mL/min/1.73m² (confirm with trial site).
• People who are reasonably independent in self-care, based on a standard performance scale used by doctors (confirm with trial site).
• People whose cancer outside the brain is not expected to be immediately life-threatening, with a survival estimate of at least 3 months in the treating doctor's opinion.
• People who are able to understand and willing to sign a written consent form.
• Women who are able to become pregnant must agree to use adequate contraception before and throughout the treatment phase of the trial.

Who may not be able to join:

• People who are unable to have a brain MRI scan.
• People who are unable to receive gadolinium (a contrast dye used in MRI scans).
• People who have widespread disease affecting the lining of the brain and spinal cord (leptomeningeal disease).
• People whose treatment would require radiation to more than 10 brain targets (for those who have never had whole-brain radiation) or more than 20 brain targets (for those who have previously had whole-brain radiation), based on the treating doctor's judgement.
• People who are currently pregnant, due to potential risks to the developing baby from gadolinium.
• People who are currently breastfeeding, due to unknown potential risks to the infant.
• People who have previously had brain-directed radiation and have brain metastases that are in or within 1cm of sensitive structures such as the brainstem, eyes, optic nerves, or optic chiasm, if those structures have already received high doses of radiation (confirm with trial site for specific dose thresholds).
• People who have previously had any form of brain-directed radiation are not eligible until the study's principal investigator has given written approval.

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