Phase 2 Head and Neck 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 aged 18 to 80 years old.
• People who have been diagnosed with head and neck cancer (confirmed by lab testing of tissue or cells) that has not spread to distant parts of the body.
• People with a type of head and neck cancer called squamous cell carcinoma (SCC) that has come back or not fully responded to treatment, and cannot be removed by surgery, after having received certain standard treatments involving radiation and/or chemotherapy.
• People with a non-squamous cell type of head and neck cancer that has come back or not fully responded to any standard treatment, and cannot be removed by surgery.
• People who are not suitable for, or who have chosen not to receive, systemic treatments (medicines that travel through the whole body, such as chemotherapy or immunotherapy).
• People who previously received a specific range of radiation to the area being treated (between 40 and 75 units of radiation dose, called Gray, for SCC; up to 75 Gray for non-SCC types).
• People for whom at least 3 months have passed since their last radiation treatment before the scheduled trial treatment.
• People for whom at least 1 month has passed since their last cancer-fighting drug before the scheduled trial treatment.
• People whose tumour can be measured by MRI or CT scan, and where the largest measurement of the tumour is 7 cm or less.
• People who have at least one tumour that can be measured using a standard medical measurement method called RECIST version 1.1.
• People who are reasonably active and able to care for themselves, as rated on a standard medical scale (a score of 0, 1, or 2 out of 4 on the ECOG scale).
• People expected to live for at least 3 months, in the opinion of the treating doctor.
• People whose blood counts and organ function (blood, liver, and kidneys) meet certain minimum levels as determined by blood tests (confirm with trial site for exact values).
• People who test negative for HIV.
• Women who could become pregnant must have a negative pregnancy test at the start of the study and again before receiving the trial drug.
• Women who could become pregnant and men who could father a child must agree to use two reliable forms of contraception throughout the study.
• People who are physically and mentally able to take part and willing to follow all study procedures.
• People who have read and signed the consent form agreeing to participate.

Who may not be able to join:

• People who have a second, separate cancer (except certain skin cancers treated successfully with surgery, or very early-stage cancers that have not spread).
• People who have multiple head and neck cancers occurring at the same time that are outside the area that can be treated by the trial's radiation beam.
• People whose cancer has spread to parts of the body outside the head and neck region.
• People whose scans show the tumour has grown into a major blood vessel in the neck called the carotid artery.
• People assessed by the treating doctor as unsuitable for the trial treatment based on specialised blood vessel imaging, in cases where carotid artery involvement is suspected.
• People who have serious ongoing side effects (Grade 3 or higher) such as severe mouth sores or skin inflammation in the area that was previously treated with radiation.
• People who have a severe cataract (Grade 3 or higher) in their eye(s).
• People who have an active infection requiring treatment with systemic medicines within 2 weeks before the screening visit.
• People who have had a heart attack, unstable chest pain, or a poorly controlled irregular heartbeat within the 6 months before the planned trial treatment.
• People with serious ongoing health conditions including poorly controlled epilepsy, diabetes, high blood pressure, serious lung diseases, serious kidney diseases, or significant heart failure (confirm with trial site for full details).
• People with a known or suspected allergy or sensitivity to the trial drug or any of its ingredients (including L-phenylalanine), or to contrast dye used in scans.
• People who have previously received the type of treatment used in this trial (called BNCT — Boron Neutron Capture Therapy).
• People with a hereditary condition called hereditary fructose intolerance.
• People with a hereditary condition called phenylketonuria.
• People who need a tooth extracted within 2 weeks before or after the trial treatment.
• People who are unable to lie or sit still in a body mould/cast for more than 30 minutes.
• People who have any medical or mental health condition that the treating doctor believes could interfere with safe participation in the study.
• People who have taken part in another clinical trial or received an experimental drug or device within 4 weeks before the screening visit.
• People with a history of substance or alcohol misuse within the 6 months before the screening visit.
• Women who plan to become pregnant or who are breastfeeding during the study period.
• People assessed by the treating doctor as otherwise unsuitable for participation.

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