Phase 2 Bladder 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:

• You are between 18 and 80 years old (inclusive), of any gender
• Your bladder cancer has not invaded the muscle layer, and is classified as high grade at stage Ta, T1, or Tis
• You have already tried a first-line bladder wash (instillation) treatment that did not work, and your bladder has been kept (or surgery to remove the whole bladder is not suitable for you for another reason)
• During your most recent bladder surgery (TURBT), tissue samples and urine tests came back showing no remaining cancer signs
• Tests of your upper urinary tract (kidneys and ureters) showed no tumors, and you have never had chemotherapy or radiation therapy for bladder cancer
• You are generally active and able to care for yourself (confirm with trial site)
• Your doctor expects you to live for more than 1 year
• Your blood counts, kidney function, liver function, and blood clotting results are all within acceptable ranges (confirm with trial site for specific numbers)
• You agree to use effective contraception during treatment and for at least 3 months afterward
• Any herpes infection you have had ended at least 3 months ago
• You are willing to follow the trial requirements and sign a consent form

Who may not be able to join:

• Your bladder cancer has grown into the muscle layer, or has spread to other parts of the body
• You had complications after your bladder surgery, or bladder wash treatments cannot be carried out for you
• You have a known allergy to GM-CSF products or to any ingredient in the study drug
• You have a serious medical condition, such as severe heart disease, stroke-related disease, uncontrolled diabetes, uncontrolled high blood pressure, severe infection, or an active stomach or bowel ulcer
• You are expected to need chemotherapy or radiation therapy during the study period
• You currently have an active infection, an unexplained fever above 38.5°C, or an ongoing urinary or bladder infection that has not fully cleared (unless it was treated with antibiotics and resolved at least 7 days after finishing the course)
• You have a condition that weakens your immune system (such as HIV), an active hepatitis B infection with detectable virus levels, or active hepatitis C infection
• You are currently pregnant or breastfeeding
• You have taken another experimental drug or antiviral treatment within the past 4 weeks
• You have taken immune-suppressing medications (such as cyclosporine, tacrolimus, or antithymocyte globulin) in the past 3 months
• You have taken part in a cancer vaccine trial (such as dendritic cell therapy or heat shock vaccine) in the past 12 months
• You have a history of substance abuse, alcohol dependency, or drug abuse
• You have been diagnosed with another cancer in the past 5 years, with some exceptions for certain low-risk or successfully treated cancers (confirm with trial site)
• You have an active autoimmune disease, or a history of one that may come back — though certain manageable conditions such as type 1 diabetes, controlled low thyroid, controlled celiac disease, or skin conditions not needing systemic treatment may be exceptions (confirm with trial site)
• You have used steroid medications as a treatment within the past 14 days, or regularly take other immune-suppressing medicines — though some limited uses such as inhalers, eye drops, or short-term preventive steroids may be exceptions (confirm with trial site)
• The trial doctors have any other concern that makes participation unsuitable for you

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