Phase 1 Bladder 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 bladder carcinoma in situ (a type of early-stage bladder cancer confined to the inner lining) confirmed by tissue testing, with or without a T1 tumour (one that has grown slightly deeper but not into the muscle wall), where the biopsy was done within the last 3 months and a recent camera examination of the bladder shows no deep muscle invasion within the last 4 weeks.
• People whose bladder cancer has not responded to BCG treatment (a common bladder cancer therapy), or who cannot tolerate BCG, meeting at least one of the following: cancer that persisted or came back within 12 months of completing a full BCG course; high-grade cancer that returned within 6 months of completing a full BCG course; or high-grade T1 disease found after the first round of BCG treatment.
• People who have declined, or been found unable to tolerate, the surgical removal of the bladder that their urologist has recommended as the standard next step.
• People aged 18 years or older.
• People with a reasonable level of physical functioning, as measured by standard medical scoring tools (confirm with trial site for exact score thresholds).
• People with a life expectancy of more than 24 months.
• People who are not currently receiving radiotherapy, chemotherapy, or other immunotherapy, and who do not have any of those treatments or surgery scheduled before the first planned assessment in this trial.
• People who have sufficiently recovered from side effects of any previous treatments, as determined by the treating urologist.
• People whose recent blood test results (taken within the last 14 days) meet the following thresholds: adequate white blood cell count, platelet count, haemoglobin level, kidney function, liver enzyme levels, and bilirubin levels (confirm with trial site for exact values; blood transfusions may be used to meet some of these thresholds).
• People with adequate lung function and no signs of serious breathing problems.
• Women of childbearing potential who have a negative pregnancy test before starting the trial.
• Women of childbearing potential who agree to use an accepted form of contraception (such as hormonal contraception, an intrauterine device, or tubal ligation) from before the screening period through to 3 months after finishing the trial; and men who agree to use barrier contraception during the trial.
• People who are willing and able to give signed informed consent and agree to follow all trial procedures and follow-up visits.

Who may not be able to join:

• People who have cancer in the upper part of the urinary tract.
• People currently taking part in another clinical trial using an investigational treatment.
• People whose cancer has spread to nearby lymph nodes or other parts of the body.
• People with serious heart conditions, including severe heart failure (NYHA Class III or IV), uncontrollable abnormal heart rhythms, any history of ventricular arrhythmia, or other signs of severe heart dysfunction.
• People who have had a heart attack, severe or unstable chest pain, or symptomatic heart failure within the 6 months before joining the trial.
• People with a bleeding disorder that cannot be controlled (for example, clotting factor deficiencies or Von Willebrand Disease).
• People taking blood-thinning or clotting-affecting medications such as Warfarin, heparin, or similar drugs (low-dose aspirin of 81 mg daily is permitted; certain anti-inflammatory medications are allowed if stopped the day before treatment).
• People with an uncontrollable condition affecting the brain or central nervous system.
• People currently being treated with intravenous antibiotics for an active infection.
• People who are pregnant or breastfeeding.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements.
• People with any other serious illness that, in the opinion of the trial investigators, would make participation unsafe or unsuitable.
• People who have been diagnosed with another cancer within the 3 years before joining the trial, except for certain low-risk cancers such as basal or squamous cell skin cancers, non-invasive cervical cancer, or other cancers considered low-risk during the trial period (such as treated localised prostate cancer with a PSA below 0.2 ng/ml).
• People who are unwilling or unable to follow the trial protocol.
• People who do not have the capacity to make their own informed decisions about participation.

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