NCT04179162View on ClinicalTrials.gov

Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 22, 2019

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Non-Muscle Invasive Bladder Cancer (NMIBC)
Interventions
DRUG

Bacillus Calmette-Guérin (BCG)

Patients will receive once-weekly intravesical BCG therapy (TICE strain, 50 mg) at weeks 2 (+/- 2 days), 3 (+/- 2 days), 5 (+/- 2 days), 6(+/- 2 days), 8 (+/- 2 days), and 9 (+/- 2 days).

DRUG

Gemcitabine

Patients will receive gemcitabine at their specified dose level, given in a twice weekly fashion, with 72 to 96 h (+/- 1 day) between doses, at weeks 1, 4, 7, and 10.

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

06102

Hartford Healthcare (Data Collection), Hartford

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER