Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy

Conditions

• Recurrent Non-Muscle Invasive Bladder Carcinoma
• Stage 0a Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BCG Solution — BIOLOGICAL
  Given intravesically
• Biopsy of Bladder — PROCEDURE
  Undergo bladder biopsy
• Cystoscopy — PROCEDURE
  Undergo cystoscopy
• Computed Tomography — PROCEDURE
  Undergo CT Scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Transurethral Resection of Bladder Tumor — PROCEDURE
  Undergo TURBT
• Gemcitabine — DRUG
  Given intravesically

Study Details

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.

Key Dates

Start date

Jul 17, 2025

Status verified

Jun 2026

Primary completion

Jun 5, 2028

Completion

Dec 5, 2028

Study Design

Enrollment

330 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (BCG)
  Patients receive BCG intravesically over 2 hours QW for 6 weeks. 2-6 weeks after completing endoscopic assessment, patients receive BCG over 2 hours QW for 3 weeks at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, CT scan/MRI and blood and urine sample collection throughout the study.
• Experimental: Arm B (BCG and gemcitabine)
  Patients receive gemcitabe intravesically over 1 hour twice weekly on weeks 1 and 10 and once weekly on weeks 4 and 7. Patients also receive BCG intravesically over 2 hours QW on weeks 2, 3, 6, 8 and 9. 2-6 weeks after completing endoscopic assessment, patients receive gemcitable intravesically over 1 hour on week 1 and BCG intravesically over 2 hours on week 2-4 at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, CT scan/MRI and blood and urine sample collection throughout the study.

Primary Outcome Measure

High Grade Recurrence-free survival (HG-RFS) [ Time Frame: Up to 5 years ]

Central Contacts

• Aishwarya Vijendran
  (773) 702-9171
  [email protected]

Locations (56)

Find similar trials in Birmingham, AL

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