Early 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 who have a brain or central nervous system (CNS) cancer that has come back, kept growing, or stopped responding to treatment, and for which no known cure exists — including certain tumour types such as medulloblastoma, high-grade gliomas, ependymomas, and similar serious brain tumours that did not respond to first-line treatment.
• People whose cancer has shown signs of getting worse, either through symptoms or on imaging scans, according to specific measurement guidelines (RAPNO criteria).
• People whose cancer has spread (metastatic disease) may still be considered.
• People who have saved tumour tissue available (either stored or fresh) for research testing as part of the trial.
• For the first three participants, age must be older than 7 and younger than 22; after those initial participants are treated successfully, the age range opens to 3 years old up to under 22 years old.
• People who have recovered from any recent surgery before starting the radiation and maintenance parts of the trial.
• People with a body surface area (a measure of body size) of at least 0.6 m² (confirm with trial site).
• People who have recovered from the side effects of any previous cancer treatments (side effects from past surgery do not count against eligibility).
• People whose last chemotherapy dose was given at least 2 weeks before receiving the study treatment (SGT-53).
• People whose last biological therapy dose was given more than 7 days before receiving the study treatment.
• People who are considered medically suitable for a specific type of focused, high-dose radiation treatment (hypofractionated irradiation), with waiting periods depending on the type of radiation previously received (confirm specific timeframes with trial site).
• People taking steroid medications (such as dexamethasone) only if the dose has been stable or reducing for at least one week before joining, and is within a specified maximum daily dose.
• People whose last dose of any short-acting growth factor medication was at least one week before treatment, or at least two weeks before treatment for long-acting versions.
• People who have been at their usual neurological baseline for at least one week before joining.
• People with a performance status score above 50 on the relevant scale for their age (a measure of how well a person can carry out daily activities), assessed within the two weeks before joining — including people who use a wheelchair due to neurological difficulties.
• People whose blood counts, liver, kidney, heart, and other organ functions meet the specific healthy ranges set out by the trial (confirm exact values with trial site).
• People of childbearing or child-fathering potential who are willing to use an acceptable form of contraception during the trial and for at least 5 months after the last study treatment.
• Female participants who are not pregnant or breastfeeding, and who have a negative pregnancy blood test at the time of joining.
• People (and/or their guardians) who are able to understand and willing to sign a written consent form.

Who may not be able to join:

• People whose tumour is a low-grade glioma, craniopharyngioma, or other non-cancerous CNS tumour.
• People diagnosed with diffuse midline gliomas (DMGs).
• People with a serious unrelated illness — such as a significant infection or major heart, lung, or liver problems — that could interfere with the ability to tolerate the trial treatment or procedures.
• People with pre-existing heart problems where the heart's pumping function (ejection fraction) is below 35%.
• People with pre-existing lung scarring (pulmonary fibrosis), inflammatory lung disease, or other significant lung conditions.
• People who are currently taking part in another clinical trial involving an investigational drug.
• People who, in the opinion of the trial doctor, would not be able to follow the trial requirements.
• People who have had an autoimmune disease requiring treatment within the last 2 years (note: abnormal lab results alone, without a formal autoimmune diagnosis, or routine hormone replacement therapies, do not automatically make someone ineligible — confirm with trial site).
• People who have received a live vaccine within 30 days before starting the study treatment.
• People with known HIV/AIDS or active or chronic Hepatitis B or C.
• People who are not permitted to receive further radiation therapy because they have already reached the maximum safe lifetime dose.

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