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ACTIVE NOT RECRUITING

NCT03091660

PHASE3

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

Official title: S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2017-02-24

Completion Date

2026-06-15

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma

Interventions

BIOLOGICAL

BCG Solution

Given intravesically

BIOLOGICAL

BCG Tokyo-172 Strain Solution

Given intravesically

BIOLOGICAL

BCG Tokyo-172 Strain Vaccine

Given ID

OTHER

Laboratory Biomarker Analysis

Correlative studies

Inclusion Criteria: * Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration * Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration * Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =\< T1 disease within 90 days prior to registration * Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification * Patients must not have pure squamous cell carcinoma or adenocarcinoma * Patients' disease must not have micropapillary components * Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms * Patients must not have nodal involvement or metastatic disease * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible * Patients must have a Zubrod performance status of 0-2 * Patients must not have received prior intravesical BCG * Patients must not have known history of tuberculosis * Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as \< 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml) * Patients must be \>= 18 years of age * Patients must not be taking oral glucocorticoids at the time of registration * Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study * Prestudy history and physical must be obtained within 90days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies

Locations (174)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

George Washington University Medical Center

Washington D.C., District of Columbia, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Island Urology-Hilo

Hilo, Hawaii, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Island Urology

Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Hawaii Cancer Care - Savio

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Carle on Vermilion

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Sparrow Hospital

Lansing, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pecos