Phase 1 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 or older
• People who have been diagnosed with a specific type of head and neck cancer (HPV-negative squamous cell carcinoma) that can be removed by surgery, including cases where the original site of the cancer is unknown
• People whose cancer can be measured on scans before surgery, following standard measurement guidelines (tumours in previously treated areas or measurable only by physical exam do not count)
• People who have had scans confirming no spread of cancer to distant parts of the body, done within the past 16 weeks
• Women who could potentially become pregnant must have a negative pregnancy test done within 7 days before joining
• People who are generally well enough to carry out normal daily activities with little or no limitation (as rated by a standard medical scale called ECOG, score 0 or 1)
• People whose recent blood test results (taken within 14 days) show their blood counts, liver function, and clotting levels are within the ranges required by the trial
• People able to give written consent to participate
• People able to complete questionnaires, either on their own or with help
• People willing to provide blood and tissue samples for research purposes
• People willing to return to the trial site for follow-up visits during the active study period
• For the second stage of the trial: people who received the pre-surgery study drug (decitabine), had the study-related surgery, and meet the criteria for follow-up radiation treatment as decided by their doctor

Who may not be able to join:

• People who are pregnant or breastfeeding
• People of childbearing potential who are not willing to use adequate contraception during the trial
• People with serious ongoing health conditions that, in the investigator's judgement, would make participation unsafe or interfere with properly assessing the treatment
• People who are immunocompromised, or people known to be HIV-positive who are currently receiving antiretroviral (HIV) treatment — note: people who are HIV-positive but do not show signs of a weakened immune system may still be eligible (confirm with trial site)
• People who have not yet recovered from side effects of previous treatments — with one exception: stable mild nerve-related sensory symptoms that have not changed for at least 3 months may be acceptable
• People with uncontrolled ongoing illnesses, including active infections, certain heart conditions, or mental health or social circumstances that would make it difficult to follow the study requirements
• People who need continuous oxygen due to breathing difficulties caused by advanced illness or other conditions
• People currently taking part in another clinical trial involving a treatment for their cancer
• People who have had another cancer within the past 5 years — exceptions include certain skin cancers and early-stage cervical changes; people with a prior cancer history must not be receiving active treatment for it
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for a serious heart rhythm problem
• People who have previously had radiation treatment to the area now affected by this cancer
• People who received chemotherapy within the past 5 years for a different condition unrelated to this cancer
• People for whom radiation therapy or the study drug decitabine is considered unsuitable by their treating medical team
• For the second stage of the trial: people who experienced a serious side effect (called a dose-limiting toxicity) during the pre-surgery phase of the study drug

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