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:

• People who have been diagnosed with a type of brain tumour called glioblastoma or gliosarcoma (either as a first diagnosis or one that developed from a lower-grade brain tumour), confirmed by laboratory testing of tumour tissue.
• People aged 18 or older.
• People who have a performance status score of 70% or higher on the Karnofsky scale, meaning they are able to carry out normal activity with only minor assistance needed (confirm with trial site).
• People who have previously received radiation therapy to the brain at full treatment doses.
• People whose brain anatomy allows new radiation dose limits to be safely planned, based on MRI and treatment planning scans.
• People whose blood counts meet minimum levels, specifically: neutrophil count (a type of white blood cell) of at least 1,000 per microlitre, and platelet count of at least 100,000 per microlitre.
• People who are able to become pregnant or father a child must agree to use effective contraception (such as barrier methods, hormonal contraception, an intrauterine device, surgical sterilisation, or abstinence) from the start of the study until at least 6 months after the last treatment. People who can father a child must also agree not to freeze or donate sperm during this period.
• People who are currently breastfeeding must be willing to stop breastfeeding from the start of treatment until at least 6 months after the last treatment.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have received certain cancer treatments too recently before starting the study — specifically: a drug called bevacizumab (used for reasons other than tumour progression or symptom management) within the past 2 weeks; temozolomide within the past 2 weeks; other chemotherapy within the past 3 weeks; or any experimental treatment within the past 2 weeks.
• People who are unable to have an MRI scan or cannot receive the contrast dye (gadolinium) used during MRI, for any reason.
• People who have received any treatment within 2 weeks after a repeat brain surgery or biopsy, prior to starting the study.
• People who have needed radiation therapy within the 12 months before starting the study.
• People who have previously been treated with Novacure TTFields (a device-based therapy), Gliadel wafers, or GammaTile therapy.
• People who test positive on a pregnancy test at the screening stage.
• People who have a known or suspected condition that makes them unusually sensitive to radiation.
• People who have other serious or unstable medical conditions that are not well controlled and could increase the risk of harm from participating, as assessed by a doctor.

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