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 aged older than 3 years and up to and including 39 years old
• People who have a brain tumour called medulloblastoma (MB) that has come back or is getting worse for the first or second time, either confirmed by tissue testing or strongly suspected
• People who have previously received radiation therapy as part of their cancer treatment
• People who have already joined a related screening study and had tumour tissue collected in a specific way suitable for the vaccine preparation used in this trial
• People who have fully recovered from side effects of previous cancer treatments, and who meet minimum waiting periods after their last treatment (for example, at least 90 days after standard radiation, at least 150 days after full brain/spine radiation, and at least 14 days after another trial drug)
• People who have never previously received a treatment targeting a protein called pp65, or any treatment using RNA-lipid particle (RNA-LP) therapy
• People who have had specific MRI brain and spine scans performed — one before surgery (within 28 days before joining) and one after surgery (within 7 days after surgery)
• People whose general health and ability to function meets a minimum score on a standard scale, assessed within 2 weeks before joining — this includes people in wheelchairs who cannot walk due to paralysis
• People whose blood counts meet minimum levels without needing medical support (confirm with trial site for exact values)
• People whose kidneys are functioning at or above a minimum level (confirm with trial site)
• People whose liver function test results are within acceptable ranges for their age (confirm with trial site)
• People taking steroid medications, provided the dose has been stable or decreasing for more than 1 week before joining, and is no more than a specified low dose equivalent — low-dose replacement therapy for hormonal conditions and topical steroids are allowed
• People who are willing to take an anti-seizure medication (such as levetiracetam) throughout the vaccination part of the trial
• People (or their legal parent or guardian) who are able to understand and willing to sign a consent form
• Women who could become pregnant must have a negative pregnancy test at the time of joining
• Women who could become pregnant must be willing to use acceptable contraception throughout the study and for at least 24 weeks after the last study treatment
• Males who could father a child must agree to use approved contraception throughout the study and for at least 24 weeks after the last study treatment
• People who have neurological changes after surgery must have those changes be stable for at least 1 week before joining
• People who must first be enrolled in a related registry study (PNOC COMP) if that registry is open at their treatment centre, before joining this trial

Who may not be able to join:

• People with certain specific types of brain tumours (diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or tumours with a specific genetic change called BRAFV600E+)
• People whose tumour is considered "bulky," meaning it is causing significant pressure effects in the brain or spine, involves more than three areas of the brain, or has spread outside the brain or spine (spinal spread may be allowed in one specific group — confirm with trial site)
• People who are known to be positive for HIV, Hepatitis B, or Hepatitis C
• People with a seizure disorder that is not well controlled
• People with a history of inflammation of the heart muscle (myocarditis)
• People who have received a live vaccine within 30 days before joining
• People with a known active infection or a condition that weakens the immune system
• People with significant problems affecting the kidneys, heart (including heart failure, heart attack, or myocarditis), lungs, liver, or other major organs
• People with severe or unstable ongoing medical conditions
• Women who are pregnant or breastfeeding
• People who are currently receiving another experimental treatment, or who have taken part in another therapeutic clinical trial within 30 days before joining
• People who are unwilling or unable to receive the study treatment or attend follow-up visits

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