Early Phase 1 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 who have been confirmed by laboratory testing to have a specific type of aggressive brain tumour called IDH-wildtype glioblastoma (grade 4), including a subtype called gliosarcoma, diagnosed according to 2021 medical guidelines.
• People whose scans show that some tumour remains after their initial brain surgery or biopsy.
• People who are considered suitable for a follow-up surgical procedure (either standard surgery or a laser-based heat treatment called LITT) to examine the remaining tumour after completing radiation and chemotherapy.
• People who are at least 18 years old.
• People whose treating doctor has determined them eligible to receive the standard radiation treatment (60 Gy) combined with a chemotherapy drug called temozolomide (TMZ).
• People who have recovered well enough from their surgery and any related complications to begin chemoradiation treatment, in the opinion of their treating doctor.
• People with a performance status score of 60 or higher on the Karnofsky scale, which measures a person's ability to carry out daily activities (confirm with trial site).
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning at adequate levels as defined by the trial (confirm with trial site for specific values).
• People with a history of HIV who are currently on effective HIV treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have been treated or are on suppressive therapy and have an undetectable viral load.
• People with a history of hepatitis C who have completed treatment and have an undetectable viral load.
• People who are willing to use an accepted form of contraception during the trial and for 6 months after the last dose of the study drug azeliragon (applies to women who could become pregnant and to sexually active men).
• People who are able to understand the study and are willing to sign an official consent form (a legal representative may sign on someone's behalf if needed).

Who may not be able to join:

• People who have previously had radiation therapy to the brain, head, or neck in a way that could overlap with the planned treatment area.
• People whose cancer has spread to the lining of the brain or to other parts of the body.
• People whose tumour has a genetic change called an IDH mutation.
• People who have taken certain medications that affect a liver enzyme called CYP 2C8 within 2 weeks or 5 half-lives before entering the study.
• People who have a digestive condition that could interfere with swallowing or absorbing oral medication.
• People currently taking part in another interventional clinical trial or who have used another experimental treatment within 30 days before entering the study (note: participation in non-interventional studies such as observational or quality-of-life studies is generally permitted).
• People who cannot safely have an MRI scan — for example, due to certain metal implants, an incompatible pacemaker, inability to lie still for extended periods, or severe kidney disease including those on dialysis.
• People who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test within 14 days of starting treatment.
• People whose psychiatric condition, or alcohol or drug use, is considered by the investigator likely to prevent them from completing the trial treatment.
• People who do not speak English, as the cognitive (thinking and memory) assessments used in the trial are only available in English.

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