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:

• People who are at least 12 months old and no older than 39 years old at the time of joining the study.
• People in Cohort A (newly diagnosed): Those diagnosed with a specific type of brain tumour called DIPG, based on MRI scans showing the tumour in the brainstem area, who have finished radiation therapy between 28 and 35 days before starting the study treatment, and who started radiation within 42 days of their diagnosis.
• People in Cohort B (returning or hard-to-treat disease): Those with DIPG or a related brain or spine tumour (called H3K27-altered high-grade glioma) whose disease has come back, kept growing, or did not respond to earlier treatment — including those with disease that has spread.
• People whose general physical ability level meets a minimum threshold on a standard medical scale (a score of at least 50 out of 100), including those who use a wheelchair but are otherwise able to get around.
• People in Cohort A who have had surgery, radiation, steroids, or certain specific medicines (temozolomide during radiation, or bevacizumab at least 21 days before joining) as prior treatment.
• People in Cohort B who have fully recovered from side effects of previous treatments before joining (with some exceptions that the trial team can assess individually).
• People in Cohort B who have waited a specific amount of time since their last treatment — the required waiting period varies depending on the type of treatment previously received (confirm with trial site for your specific situation).
• People whose bone marrow, kidneys, liver, and heart are functioning at levels that meet specific minimum standards based on blood and imaging tests.
• People in Cohort B with a history of seizures, as long as the seizures have been well-controlled with no increase in the 7 days before joining.
• People who are willing and able to sign a consent form (or whose parent or legal guardian can sign on their behalf).
• People without any other serious active medical condition that would affect their participation, in the opinion of the treating doctor.

Who may not be able to join:

• People in Cohort A whose tumour has spread to other parts of the body.
• People in Cohort B who are taking corticosteroid medicines (such as steroids) whose dose has not been stable or decreasing for at least 7 days before joining.
• People who are currently taking any other anti-cancer treatment not permitted under the study rules.
• People currently taking another experimental/investigational drug as part of another study.
• People taking certain types of anti-seizure medicines known as enzyme-inducing anticonvulsants.
• People taking hormone-related medicines called LHRH agonists or antagonists.
• People taking high-dose Biotin (Vitamin B7) supplements.
• People with an uncontrolled infection at the time of joining.
• People who have previously received a solid organ transplant (such as a kidney or liver transplant).
• People who have previously received an allogenic stem cell transplant (a stem cell transplant using cells from a donor).
• People who are pregnant or breastfeeding.
• People who are capable of becoming pregnant or fathering a child who are unwilling to use effective contraception during the study and for 3 months after finishing treatment.
• People who, in the opinion of the treating doctor, may not be able to safely follow the study's monitoring requirements.
• People who have previously received either of the study drugs: ACT001 or parthenolide.

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