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:

General requirements for all arms:

• Children and young adults aged 2 and above (some arms require age 2–21 for the dose escalation phase, with 2 and above for the dose expansion phase) with a confirmed brain or spinal cord tumour diagnosis, depending on which arm of the trial applies.
• Tumour tissue must have been confirmed by a pathologist, and in most arms the tumour must show a specific genetic change called "H3K27 altered" (confirm with trial site for which arm applies).
• People who have recovered from all serious short-term side effects of any previous treatment.
• People whose blood cell counts, kidney function, and liver function fall within the ranges required by the trial (confirm with trial site for specific numbers).
• People who are taking steroid medications must have been on a stable or reducing dose for at least 3 days before joining.
• People with a seizure disorder may be eligible if their seizures are well controlled.
• People who are well enough to carry out basic daily activities, based on standard medical performance scoring (confirm with trial site for specific score thresholds); people who use a wheelchair due to paralysis may still meet this requirement.
• People who are able to provide a sufficient amount of stored tumour tissue samples (a minimum number of slides or a tissue block with enough tumour present).
• A parent, guardian, or the participant themselves must be willing and able to sign a consent form.
• People who are also enrolled in a related registry study called PNOC COMP, if that registry is open at the enrolling hospital.

Arm A specifically (DMG, H3K27 altered — after radiation):

• People diagnosed with a brain tumour called Diffuse Midline Glioma (DMG) with the H3K27 alteration, who have completed at least one previous treatment including targeted radiation therapy, and who are enrolling between 4 and 14 weeks after finishing that radiation, with no sign of the tumour growing since then.
• People who have not started any other new treatments since completing radiation therapy.
• People whose previous treatments ended far enough in advance (specific waiting periods apply depending on the type of treatment received — confirm with trial site).

Arm B specifically (DMG, H3K27 altered — newly diagnosed):

• People newly diagnosed with DMG (including tumours in the spinal cord) who have not yet received treatment, with pathology confirming the H3K27 alteration.

Arm C specifically (DMG, H3K27 altered — tumour has come back, re-irradiation planned):

• People with DMG, H3K27 altered whose tumour has shown signs of returning or growing, who have not yet received treatment for this recurrence, and for whom the treating team has recommended a further course of radiation therapy.
• People who previously had targeted radiation as part of their initial treatment, ideally at least 6 months before joining this arm (cases with less than 6 months may be discussed with the study team).
• People whose previous treatments ended far enough in advance (specific waiting periods apply — confirm with trial site).

Arm D specifically (other malignant brain or spinal cord tumours, not DMG — tumour has come back):

• People with a recurrent malignant brain or spinal cord tumour (other than DMG, though ependymoma is allowed) whose tumour has shown signs of growing and who have not yet received treatment for this recurrence.
• People who had surgery for the recurrence may be eligible if surgery was not intended to be curative — these cases need to be discussed with the study team.
• People whose previous treatments ended far enough in advance (specific waiting periods apply — confirm with trial site).

Target Validation group (tissue collection only):

• People aged 2 and above who are newly diagnosed with a tumour that looks like DMG, H3K27 altered on imaging, or who have a recurrent malignant brain or spinal cord tumour, and who are already having tumour tissue collected as part of their standard medical care.

Who may not be able to join:

• People in Arms A or B whose tumour is located in the thalamus or cerebellum with the H3K27 alteration and who received standard radiation without any additional treatment alongside it (other than a specific chemotherapy called temozolomide).
• People in Arms C or D who previously participated in a trial testing a related drug called ONC201 as an upfront (first-line) treatment (prior ONC201 use through certain other programs may be allowed — confirm with trial site).
• People who are currently taking part in another clinical trial involving an experimental drug.
• People who are currently receiving any other cancer treatment.
• People with a known condition that affects the immune system, such as HIV or hepatitis B or C, or an autoimmune condition requiring strong immune-suppressing medication (use of certain non-oral or non-intravenous steroids may not automatically exclude someone — confirm with trial site).
• People with an infection that is not currently under control.
• People who are pregnant or breastfeeding; a negative pregnancy test is required before starting treatment for anyone who could become pregnant.
• People with active illegal drug use or a diagnosis of alcoholism.
• People who have previously had a significant allergic reaction to a drug similar in composition to the study drug ONC206.
• People who, for any reason such as language barriers, psychological difficulties, or cognitive impairment, would be unable to follow the trial's procedures.
• People with a condition that may affect how their body absorbs the study drug when taken by mouth.
• People currently taking certain medications that strongly interact with the way the body processes ONC206 (specific drug interaction categories apply — confirm current medications with the trial site at least 14 days before starting).

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