Phase 2 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 cancer (specifically urothelial carcinoma) confirmed by a tissue sample, with no involvement of the upper urinary tract or the part of the urethra that passes through the prostate.
• People whose bladder cancer is either carcinoma in situ (CIS, a very early form of cancer confined to the inner lining), with or without non-invasive tumours (stages Ta or T1 of any grade), or high-grade papillary tumours (stages Ta or T1) without CIS.
• People whose bladder cancer has stopped responding to BCG treatment, based on specific FDA-accepted criteria — for example, if high-grade T1 cancer appeared after at least 5 out of 6 BCG induction treatments, or if CIS returned within 12 months (or high-grade papillary disease within 6 months) after a full course of BCG therapy.
• People who have had all visible bladder tumours completely removed within 8 weeks before starting the study treatment, or who have had a recent check procedure (cystoscopy) confirming no tumour regrowth if more than 8 weeks have passed since removal.
• People who are medically eligible for bladder removal surgery (radical cystectomy) but have chosen not to have it, or who are not suitable for that surgery due to other health conditions.
• People aged 18 or older who are able to read, understand, and sign a consent form.
• People with a general health and activity level rated 2 or below on a standard medical scale (ECOG), meaning they are able to care for themselves even if unable to do physically strenuous activity (confirm with trial site).
• People who have not received any bladder-directed (intravesical) or upper urinary tract topical treatment within 8 weeks before joining the trial.
• People who are willing and able to use effective contraception (such as an IUD, birth control pills, Depo-Provera, and/or condoms) during treatment and for 3 months after the last dose of study treatment, if there is any possibility of becoming pregnant.
• People who have had a negative pregnancy test at the screening visit, if pregnancy is possible for them.
• People who have had appropriate blood tests (complete blood count) within 30 days before their tumour removal or biopsy, and/or within 14 days before starting study treatment.
• People who are willing and able to follow all study requirements and give informed consent.
• People enrolled in other clinical trials must have completed their last intravesical treatment at least 8 weeks before joining, or if they received a systemic immune-modifying treatment (such as checkpoint inhibitors), at least two full dosing intervals must have passed without treatment before the trial site would consider them eligible.

Who may not be able to join:

• People who have had, or currently have, bladder cancer that has grown into the muscle wall of the bladder (stage T2 or higher).
• People who have had, or currently have, cancer in the upper urinary tract (kidneys or ureters) or in the part of the urethra that passes through the prostate.
• People whose bladder cancer is a less common type, such as squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid carcinoma, nested carcinoma, sarcomatoid carcinoma, or cancer that has spread from another part of the body.
• People with another active cancer, unless it is a slow-growing or well-controlled prostate cancer, a basal or squamous cell skin cancer, or a non-invasive cervical condition that is not expected to affect survival over the next 3 years.
• People who have had a severe allergic reaction (grade 3 or higher) to gemcitabine or docetaxel, or to any drug containing polysorbate 80 (an ingredient in docetaxel).
• People who are currently receiving any other chemotherapy treatment directed into the bladder or taken systemically, or who have not completed an 8-week washout period since their last such treatment.
• People who have received a checkpoint inhibitor (a type of immune therapy) within 2 treatment cycles before joining.
• People who have had major surgery within 3 months before joining.
• People whose blood test results show that the bone marrow or organs (such as the liver or kidneys) are not functioning well enough, based on specific laboratory thresholds set by the trial (confirm specific values with trial site).
• People who have previously had radiation treatment to the pelvis.
• People who have had significant difficulty with bladder catheterisation in the past, which in the treating doctor's judgement could prevent safe delivery of the bladder treatment.
• People with a history of interstitial cystitis (a chronic bladder condition), or who are currently unable to hold approximately 2 ounces (about 60 mL) of fluid in the bladder for around 60 minutes.
• People with an active, uncontrolled bacterial, viral, or fungal infection that requires treatment with systemic (whole-body) medication.
• People with a known diagnosis of HIV, Hepatitis B, or Hepatitis C.
• People who have had a COVID-19 infection within 30 days before joining, or who are currently experiencing COVID-related symptoms.
• People with significant recent heart-related events, such as coronary stenting within the past 8 weeks or a heart attack within the past 6 months.
• People who are currently pregnant or breastfeeding.
• People who have taken part in another research trial involving an experimental treatment within 6 weeks before joining (an 8-week washout is required).
• People with any other serious or unstable health condition that, in the treating doctor's opinion, could affect their ability to participate safely over the full 5 years of the study.

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