Phase 2 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:

• The child must have a suspected or confirmed new diagnosis of a brain tumour called medulloblastoma.
• The child must be under 60 months (5 years) of age at the time of joining the study.
• During the initial screening stage, the child must be either under 36 months old, or between 36 and 60 months old with a suspected non-spreading form of the disease.
• A sufficient sample of tumour tissue must be available so that specialists at a central laboratory can review and classify the tumour type.
• Treatment must be able to start within 36 days of the main surgery (confirm with trial site).
• The child's disease must be assessed by MRI scans of the brain and spine, and a sample of the fluid around the brain and spinal cord (unless this procedure is medically not safe).
• The child must not have received any previous radiation therapy, chemotherapy, or other brain tumour treatments — surgery and steroid medicines are acceptable.
• The child must have a basic level of physical function as measured by a standard medical score (called the Lansky score) above 30, except in certain cases involving a condition called posterior fossa syndrome.
• Blood test results must show that the child's bone marrow, liver, and kidneys are working adequately according to specific thresholds set by the trial (confirm with trial site for exact values).
• A parent or legal guardian must be willing and able to sign a consent form agreeing to take part.

For Stratum S-2 specifically (one treatment group):

• The child's tumour must be centrally confirmed as a specific subtype called SHH-2 medulloblastoma.
• The child must be either under 36 months old, or between 36 and 60 months old with no spread of disease.

For Stratum S-1 specifically (another treatment group):

• The child's tumour must be centrally confirmed as one of the following subtypes: SHH-1, SHH-2, SHH-3, SHH-4, or SHH-NOS medulloblastoma.
• The child must be under 36 months old at the time of joining.

For Stratum N specifically (another treatment group):

• The child's tumour must be centrally confirmed as Group 3, Group 4, or a non-SHH/unclassified medulloblastoma subtype.
• The child must be under 36 months old at the time of joining.

Who may not be able to join:

• Children whose brain tumour is a different type, such as ATRT, PNET, Pineoblastoma, Ependymoma, or ETMR — only medulloblastoma is eligible.
• Children who have already received radiation therapy, chemotherapy, immunotherapy, or targeted drug treatments for their brain tumour.
• Children currently taking part in another clinical trial involving an experimental treatment.
• Children with other serious health conditions — such as significant heart, lung, liver, or psychiatric problems, or serious infections — that could interfere with their ability to tolerate the treatment or affect the study results.
• Children whose tumour classification is not confirmed through the central review process at the designated central laboratory (no outside testing is accepted for enrolment purposes).

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