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
Start Date
7/17/2025
Completion Date
12/5/2028
Summary
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.
Detailed Description
PRIMARY OBJECTIVE: I. To compare high-grade recurrence-free-survival between treated with gemcitabine with BCG (GemBCG) compared to those treated with BCG alone. SECONDARY OBJECTIVES: I. To compare the proportion of patients who remain high grade cancer free on initial post-treatment cystoscopic biopsies/transurethral resection of bladder tumor (TURBT) (week 13/month 3) between those treated with GemBCG compared to those treated with BCG alone. II. To compare the 6-month (Week 25) complete response rate and the complete response durability between patients treated with GemBCG compared to those treated with BCG alone among patients with pre-treatment CIS. III. To compare the time to recurrence of any-grade bladder cancer between patients treated with GemBCG compared those treated with BCG alone. IV. To compare the progression-free-survival between patients treated with GemBCG compared to those treated with BCG alone. V. To compare the cystectomy-free-survival between patients treated with GemBCG compared to those treated with BCG alone. VI. To compare the proportion of patients free from BCG-unresponsive NMIBC between those treated with GemBCG compared to those treated with BCG alone. VII. To determine the safety of and toxicity associated with GemBCG treatment relative to that of BCG treatment alone. EXPLORATORY OBJECTIVE: I. To collect tumor tissue/bladder biopsies, blood, and urine samples for biobanking that will enable future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive BCG intravesically over 2 hours once per week (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, computed tomography (CT) scan/ magnetic resonance imaging (MRI) and blood and urine sample collection throughout the study. ARM B: 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. After completion of study treatment, patients are followed every 3 months for 2 years, then every 6 months for 3 years up to 5 years from randomization.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BCG Solution
Biopsy of Bladder
Cystoscopy
Computed Tomography
Magnetic Resonance Imaging
Biospecimen Collection
Transurethral Resection of Bladder Tumor
Gemcitabine
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois 60160
United States
IU Health West Hospital
Avon, Indiana 46123
United States
IU Health North Hospital
Carmel, Indiana 46032
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
IU Health Methodist Hospital
Indianapolis, Indiana 46202
United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana 70002
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
FMH James M Stockman Cancer Institute
Frederick, Maryland 21702
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Lahey Clinic
Burlington, Massachusetts 01805
United States
Lahey Clinic Peabody
Peabody, Massachusetts 01960
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Great Falls Clinic
Great Falls, Montana 59405
United States
Hi-Line Sletten Cancer Center
Havre, Montana 59501
United States
Benefis Helena Specialty Center
Helena, Montana 59601
United States
Logan Health Medical Center
Kalispell, Montana 59901
United States
Community Medical Center
Missoula, Montana 59804
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania 18519
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Fox Chase Cancer Center-Rockledge
Rockledge, Pennsylvania 19046
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Memorial Hospital of Laramie County
Cheyenne, Wyoming 82001
United States
Billings Clinic-Cody
Cody, Wyoming 82414
United States