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:

For people with returning or worsening medulloblastoma (a type of brain tumour) — Stratum I:

• People who are between 3 and 39 years old at the time of joining the trial.
• People who have been diagnosed with medulloblastoma that has come back, is getting worse, or is not responding to treatment, confirmed by a tissue sample taken either at first diagnosis or when the cancer returned.
• People whose tumour can be measured in two directions on an MRI scan.
• People whose cancer has spread to other parts of the brain or spine are eligible.
• People who score at least 50 on standard medical functioning scales (which measure ability to carry out daily activities) — patients who use a wheelchair due to paralysis may still meet this requirement (confirm with trial site).
• People who have previously received radiation therapy as part of their original treatment, unless they were under 4 years old at the time of joining (in which case prior radiation is not required).
• People whose last full spinal/brain radiation treatment or large-area radiation was completed more than 3 months before joining the trial.
• People whose last targeted (focal) radiation treatment was completed more than 4 weeks before joining.
• People whose last dose of chemotherapy that affects bone marrow was given at least 21 days before joining.
• People whose last dose of immunotherapy was given at least 30 days before joining.
• People whose last dose of non-bone-marrow-affecting cancer treatment was given at least 7 days before joining.
• People whose last dose of antibody-based cancer treatment was given at least 21 days before joining.
• People whose last dose of blood cell growth factor treatment was given at least 14 days (long-acting) or 7 days (short-acting) before joining.
• People who had a stem cell infusion at least 90 days before joining.
• People whose blood counts meet minimum levels — specifically, white blood cells, platelets, and haemoglobin are at or above specified thresholds (confirm exact values with trial site).
• People whose kidneys are functioning at an adequate level based on age- and sex-specific blood test thresholds (confirm with trial site).
• People whose liver function test results are within acceptable ranges (confirm with trial site).
• People whose neurological symptoms (such as weakness or movement problems) have been stable for at least 2 weeks before joining.
• People who have a seizure disorder that is well controlled with medication.
• People who are able to become pregnant or father a child and are willing to use an effective form of contraception (including abstinence) during the trial and for three months after treatment ends.
• People (or their guardians) who are able to provide signed consent according to the trial site's guidelines before joining.

For people with newly diagnosed high-grade brain tumours (HGG) — Stratum II (NOTE: This group is not currently enrolling):

• People who are between 3 and 39 years old at the time of joining.
• People with a newly diagnosed high-grade brain tumour confirmed by tissue sample (such as certain types of aggressive gliomas), enrolling within 6 weeks of finishing standard radiation therapy.
• People with tumours located in the spinal cord are eligible.
• People with cancer that has spread to other parts of the brain or spine are eligible.
• People who score at least 50 on standard medical functioning scales — patients who use a wheelchair due to paralysis may still meet this requirement (confirm with trial site).
• People who have received no prior treatment other than surgery, radiation, chemotherapy given during radiation, and/or steroid medication.
• People who received radiation at a standard dose (54–59.4 Gy) over approximately 6 weeks, beginning within 42 days of surgery (confirm details with trial site).
• People who received the drug bevacizumab before joining, provided their last dose was at least 14 days before enrollment.
• People whose blood counts, kidney function, and liver function meet the minimum levels described above for Stratum I (confirm with trial site).
• People whose neurological symptoms have been stable for at least 1 week before joining.
• People who are able to become pregnant or father a child and are willing to use an effective form of contraception during the trial and for 3 months after treatment ends.
• People (or their guardians) who are able to provide signed consent before joining.

For people with newly diagnosed DIPG (a type of brain stem tumour) — Stratum III:

• People who are between 3 and 39 years old at the time of joining.
• People with a newly diagnosed DIPG — either confirmed by MRI scan showing a tumour centred in a specific part of the brain stem covering more than two-thirds of that area, or confirmed by a tissue sample showing a certain type of brain tumour (confirm with trial site).
• People with cancer that has spread to other parts of the brain or spine are eligible.
• People who score at least 50 on standard medical functioning scales — patients who use a wheelchair due to paralysis may still meet this requirement (confirm with trial site).
• People who have received no prior treatment other than surgery, radiation, chemotherapy given during radiation, and/or steroid medication, enrolling within 6 weeks of finishing standard radiation.
• People who received radiation at a standard dose of 54 Gy over approximately 6 weeks, beginning within 42 days of diagnosis or biopsy (confirm with trial site).
• People whose blood counts, kidney function, and liver function meet the minimum levels described above (confirm with trial site).
• People whose neurological symptoms have been stable for at least 1 week before joining.
• People who are able to become pregnant or father a child and are willing to use an effective form of contraception during the trial and for 3 months after treatment ends.
• People (or their guardians) who are able to provide signed consent before joining.

Who may not be able to join (applies to all groups):

• People who are currently pregnant or breastfeeding.
• People who are able to become pregnant or father a child and are not willing to use an effective form of contraception during the trial and for 3 months after treatment ends.
• People who currently have an active infection that requires treatment.
• People with a known history of HIV, hepatitis B surface antigen, or hepatitis C antibody.
• People whose cancer is related to HIV infection or who have had a solid organ transplant.
• People with a known condition that weakens the immune system.
• People with active or significant kidney, heart, or moderate-to-severe lung problems that require medical treatment or that limit everyday activities — this includes conditions such as chronic lung disease, asthma, or having had part of a lung removed (confirm with trial site).
• People currently taking medications that suppress the immune system (inhaled steroids for asthma are allowed).
• People currently receiving any other cancer-directed treatment at the same time as this trial.
• People currently participating in another clinical trial involving an investigational drug.
• People taking the steroid medication dexamethasone at a dose higher than a specified daily limit (confirm exact threshold with trial site).
• People with any other significant unrelated illness, such as serious infections or significant problems with the heart, lungs, or liver.
• People who are not able to attend follow-up visits or complete the required tests to monitor for side effects.
• People considered to be at high risk of rapid neurological decline due to the size or location of their tumour as seen on MRI (the trial team would need to be consulted about these cases).

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