Phase 3 Hearing Loss 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:

• You must be between 4 and 21 years old at the time of joining the trial
• You must have been newly diagnosed with a brain tumor called medulloblastoma, confirmed by specialist review
• Your tumor must not have spread to other parts of the brain or spine (called "M0 disease")
• Your tumor must not be of a specific aggressive type called "diffuse anaplastic histology"
• Your tumor must match certain molecular (genetic) patterns — either a specific SHH type with normal markers, a Group 3 type with normal MYC, or a Group 4 type — as confirmed by specialist testing (confirm with trial site)
• A fluid test from your lower spine (lumbar puncture) must show no cancer cells
• After surgery, the amount of tumor remaining must be no more than 1.5 cm² in size, confirmed by brain and spine MRI scans with contrast dye
• You must weigh more than 10 kg (about 22 pounds)
• Treatment must be planned to start no later than 31 days after your surgery
• Your blood counts must be at a healthy enough level, checked within 7 days before joining (specific levels required — confirm with trial site)
• Your kidneys must be working well enough, based on a blood or urine test within 7 days before joining
• Your liver must be working well enough, based on blood tests within 7 days before joining
• If you have a seizure condition, it must be well controlled with medication
• You must have normal hearing in at least one ear, confirmed by a specialist hearing review
• You and/or your parent or legal guardian must agree to and sign a consent form
• Certain tissue samples must be submitted for specialist review as soon as possible, ideally within 5 days of surgery

Who may not be able to join:

• People whose cancer has spread to other parts of the brain or spine, or whose spine fluid test shows cancer cells
• People who cannot have a lumbar puncture (spinal fluid test) performed
• People who have already received radiation therapy or chemotherapy for this tumor (surgery and steroids are allowed)
• People who have a known allergy or sensitivity to a drug called STS, sulfates/sulfites, or similar medicines such as amifostine or MESNA
• People who are currently pregnant, as some study drugs may harm an unborn baby (a pregnancy test will be required for females who could potentially be pregnant)
• Females who are breastfeeding and plan to continue breastfeeding during the trial
• Sexually active participants who could have children and who have not agreed to use an effective method of contraception for the duration of the trial
• People who are in a coma, on a breathing machine, or having a prolonged seizure at the time of joining

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