Phase 2 Brain Cancer 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 are aged 3 years or older and under 30 years old at the time of joining the study
• People who have been newly diagnosed with a specific type of brain tumour (called a non-germinomatous germ cell tumour, or NGGCT) located in the suprasellar region (near the base of the brain) and/or pineal region (near the centre of the brain), or in both locations at once, confirmed by tissue sample or by abnormal levels of certain proteins in the blood or spinal fluid
• People whose tumour tissue contains certain cell types, including endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant or immature teratoma, or a mixed germ cell tumour that includes any of these elements
• People who have had a brain MRI scan (with and without contrast dye) before joining, and a spine MRI scan with contrast dye before joining
• People who have had a sample of spinal fluid taken from the lower back before joining (unless this is medically unsafe)
• People whose recent blood tests show that their bone marrow, kidneys, and liver are working well enough — specific cut-off values apply based on age (confirm with trial site)
• People who do not have a serious, uncontrolled seizure disorder — those with well-controlled seizures on medication may still be considered
• People who are not in a coma, not having continuous uncontrolled seizures, and not on a breathing machine before joining
• People who are able to start treatment within 31 days of their surgery or confirmed diagnosis, whichever is later
• People (and/or their parent or legal guardian) who are willing and able to sign a written consent form
• People who speak English, Spanish, or French (those who speak other languages may still join the main trial but would not take part in the thinking and quality-of-life assessments)
• People who do not have a known history of a neurodevelopmental condition (such as Down syndrome, Fragile X, or intellectual disability) before their tumour diagnosis — people with NF1 (neurofibromatosis type 1) may still be considered
• People at a trial site that has a psychologist available may also be eligible to take part in an additional thinking-skills assessment component

Who may not be able to join:

• People whose tumour is located outside the ventricles, such as in the basal ganglia or thalamus
• People whose tumour contains only mature teratoma and whose protein marker levels were not elevated at diagnosis
• People who have already received any cancer-directed treatment for this tumour, other than surgery or steroid medications
• People whose cancer has spread (shown by MRI, spinal fluid testing, or findings during surgery)
• People who are currently pregnant (note: because this tumour type can affect pregnancy test results, the trial site will use other methods to confirm pregnancy status)
• People who are breastfeeding and plan to continue doing so during the study
• People who are sexually active and able to have children, and who have not agreed to use effective contraception for the full duration of the study

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