Phase 3 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:

• You (or your child) have been diagnosed with a type of brain tumor called DIPG or a related midline brain tumor (DMG), either based on scans and symptoms, a tissue sample (biopsy), or a liquid sample from the blood or spinal fluid.
• A tissue sample (biopsy) has been done, or one can be safely performed, or tumor material is already available for testing.
• Age is older than 6 months, with no upper age limit (children between 6 months and 3 years will be considered individually based on whether a biopsy is safely possible).
• You or your child is able to receive radiation therapy to the brain or spine.
• This is a new diagnosis — no chemotherapy has been given for this tumor before, and no previous radiation therapy to the brain has been received (even for a different cancer). Surgery for diagnosis or treatment is allowed.
• Tumors that have spread (including to the spine) are allowed; in these cases, radiation will be given first, and other study medications will start only after radiation is finished.
• You or your child is covered by a social security or health insurance system as required in your country.
• Written consent from parents or legal guardians (and the patient, where appropriate) is provided before any study procedures begin.

Who may not be able to join:

• There is a severe, uncontrolled bleed inside the tumor that cannot be managed (bleeding that is under control after surgery is generally allowed).
• You or your child is receiving any other cancer treatment not included in this study (some medications like corticosteroids and bevacizumab are permitted under specific conditions).
• Another cancer has been diagnosed within the last 5 years.
• There is a serious illness or active infection that is not under control.
• There is another health condition that, in the doctor's opinion, would prevent safe participation in the study.
• Medical follow-up is not possible due to geographic, social, or mental health reasons.
• Previous radiation treatment was given to the brainstem for a different cancer.
• You or your child is currently taking part in another clinical trial using an experimental treatment.
• The patient is under legal guardianship, has had their freedom restricted by a legal or administrative decision, or is unable to give consent.
• There is significant organ damage (grade 2 or above), especially involving the heart or kidneys — including certain heart rhythm problems, kidney disease, or uncontrolled high blood pressure (confirm with trial site).
• Specific heart problems (such as a prolonged QT interval on a heart tracing, a history of certain dangerous heart rhythms, heart failure, or a family history of a specific heart condition) may prevent use of one of the study drugs (ONC201), though the other drug (Everolimus) may still be an option.
• Currently pregnant or breastfeeding.
• Patients of childbearing or fathering potential who are not willing or able to use highly effective contraception throughout the study and for 6 months after treatment ends.
• A negative pregnancy test has not been confirmed within one week before joining the treatment part of the study (for females who could become pregnant).
• Blood counts, liver function, kidney function, or clotting tests are outside acceptable ranges (confirm with trial site for specific values).
• A rare inherited condition affecting how the body processes certain sugars (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption) — these patients may still receive one of the study drugs.
• A known allergy to Everolimus or related drugs — these patients may still receive the other study drug (ONC201).
• A known allergy to ONC201 or its ingredients — these patients may still receive Everolimus.

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