Actively Recruiting
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
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-04-07
330
Participants Needed
56
Research Sites
176 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic confirmation of high grade urothelial carcinoma (Ta, T1, or carcinoma in situ) within 120 days prior to randomization
- All visible papillary lesions removed by transurethral resection of bladder tumor within 90 days of randomization
- Restaging transurethral resection of bladder tumor within 90 days for patients with high grade T1
- Recurrent high grade non-muscle invasive bladder cancer within 24 months of last BCG exposure, not meeting BCG unresponsive disease
- More than one prior induction or maintenance BCG allowed if not currently BCG unresponsive
- Prior intravesical chemotherapy or systemic agents for NMIBC allowed
- No history of intolerance to BCG or other intravesical therapies
- Bladder function not compromised to tolerate further intravesical therapies
- No history or current evidence of muscle-invasive, locally advanced unresectable, or metastatic urothelial carcinoma
- History of treated upper tract urothelial carcinoma without residual disease allowed
- History or current non-invasive urothelial carcinoma of prostatic urethra allowed with prior TURP
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months allowed
- Age 18 years or older
- Prior or concurrent malignancies allowed if not interfering with study safety or efficacy
- Not pregnant or nursing; women of childbearing potential must have negative pregnancy test within 14 days prior to randomization
You will not qualify if you...
- Presence of any neuroendocrine carcinoma component
- Pure squamous cell carcinoma or pure adenocarcinoma without urothelial component
- BCG-unresponsive NMIBC defined by specific recurrence timing and treatment criteria
- Intolerance to BCG or other intravesical therapies
- Compromised bladder function unlikely to tolerate further therapies
- Evidence of muscle-invasive, locally advanced unresectable, or metastatic urothelial carcinoma
- Pregnant or nursing women
- Patients not meeting the specified criteria for prior BCG exposure or timing of recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 56 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
5
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
6
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
7
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
8
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
9
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
10
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
11
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
12
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
13
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
14
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
15
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States, 60160
Actively Recruiting
16
IU Health West Hospital
Avon, Indiana, United States, 46123
Actively Recruiting
17
IU Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
18
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
19
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
20
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States, 70002
Actively Recruiting
21
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
22
FMH James M Stockman Cancer Institute
Frederick, Maryland, United States, 21702
Actively Recruiting
23
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
24
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
25
Lahey Medical Center-Peabody
Peabody, Massachusetts, United States, 01960
Actively Recruiting
26
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
27
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
28
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
29
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
30
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
31
Great Falls Clinic
Great Falls, Montana, United States, 59405
Actively Recruiting
32
Hi-Line Sletten Cancer Center
Havre, Montana, United States, 59501
Actively Recruiting
33
Benefis Helena Specialty Center
Helena, Montana, United States, 59601
Actively Recruiting
34
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
35
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
36
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
37
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
38
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
39
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
40
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
41
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
42
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
43
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
44
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
45
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
46
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
47
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
48
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States, 18519
Actively Recruiting
49
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Actively Recruiting
50
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
51
Fox Chase Cancer Center-Rockledge
Rockledge, Pennsylvania, United States, 19046
Actively Recruiting
52
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
53
Ralph H Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
Actively Recruiting
54
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
55
Memorial Hospital of Laramie County
Cheyenne, Wyoming, United States, 82001
Actively Recruiting
56
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Actively Recruiting
Research Team
A
Aishwarya Vijendran
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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