Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 aged 12 months to 39 years old at the time of initial screening (for the early feasibility part of the trial, only people under 21 years old are eligible)
• People who have been newly diagnosed with a high-grade brain tumour (HGG), including a type called DIPG, confirmed through a biopsy or surgical sample — no exceptions
• People whose tumour has specific genetic changes related to cell growth or a particular biological pathway (such as changes in genes like CDK4, CDK6, CDKN2A, PTEN, PIK3CA, or others listed in the trial — confirm exact details with the trial site), or for one group, a specific mutation called H3G34
• People whose tumour was confirmed through the trial's own screening process (called TarGeT-SCR)
• People who have received standard radiation therapy (photon or proton beam) at the required dose, starting within 42 days of their diagnosis
• People who are enrolling between 28 and 35 days after finishing radiation therapy
• People whose prior treatment was limited to surgery, radiation, dexamethasone (a steroid), temozolomide given alongside radiation, or bevacizumab (Avastin) given more than 21 days before enrolment — no other prior cancer treatments are permitted
• People who have adequate bone marrow function, meaning blood cell counts are within acceptable ranges as tested by a doctor
• People who have adequate kidney function, as measured by specific blood or urine tests
• People who have adequate liver function, including normal enough levels of liver enzymes and proteins
• People who have adequate heart function, including a heart pumping strength of at least 50% and a normal heart rhythm measurement (QTc of 450 msec or less)
• People with a seizure disorder may still be eligible, provided seizures are well-controlled with medications that do not strongly affect a liver enzyme system called CYP3A4/5
• People with no breathing difficulties at rest and acceptable oxygen levels
• People who are able to swallow the study medications by mouth (for the ribociclib and everolimus part of the trial, medications cannot be given through a feeding tube)
• People, or their parents or legal guardians, who are able to provide written consent to participate
• People of childbearing or child-fathering potential who are willing to use a highly effective form of contraception during treatment and for 3 months after

Who may not be able to join:

• People who are pregnant or breastfeeding
• People whose tumour shows a specific genetic change called homozygous (biallelic) RB1 loss
• People who are currently taking another experimental drug
• People who are currently receiving other cancer treatments, except temozolomide given at the same time as radiation
• People taking strong medications that significantly affect how the body processes certain drugs (strong inducers or inhibitors of CYP3A4/5), including certain anti-seizure medications — these must not have been taken within 14 days before enrolment
• People taking medications known to affect heart rhythm (QTc-prolonging drugs)
• People taking blood-thinning medication warfarin or similar coumadin-based anticoagulants (certain other blood thinners may be permitted — confirm with trial site)
• People with an active, uncontrolled infection
• People with a significant condition affecting the absorption of medications
• People with a serious ongoing medical or psychiatric condition that, in the doctor's opinion, could affect safety or the reliability of trial results
• People who, in the doctor's opinion, may not be able to follow the safety monitoring requirements of the trial

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