Bladder Cancer MSK 19-374

Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients with BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.

Eligibility Criteria:

• Recurrent high-grade NMIBC (Tis, TaHG, or T1) within 24 months of the last treatment with BCG (with or without IFN)
• Pathologic confirmation of stage, grade, and urothelial histology by the Department of Pathology at MSK
• All visible papillary lesions macroscopically resected within 60 days of treatment initiation
• Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment
• Receipt of restaging transurethral resection (TUR) for any tumor with invasion into the lamina propria (HGT1) as part of standard care
• Karnofsky performance status ≥60%
• No known contraindications to BCG

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut, Midstate Medical Center