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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091660
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma Biological: BCG Solution Biological: BCG Tokyo-172 Strain Solution Biological: BCG Tokyo-172 Strain Vaccine Other: Laboratory Biomarker Analysis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 969 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Arm I (BCG solution)
INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.
Biological: BCG Solution
Given intravesically
Other Names:
  • Bacillus Calmette-Guerin Solution
  • TICE BCG Solution

Other: Laboratory Biomarker Analysis
Correlative studies

Experimental: Arm II (Tokyo-172 strain BCG solution)
INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.
Biological: BCG Tokyo-172 Strain Solution
Given intravesically
Other Names:
  • Bacillus Calmette-Guerin Tokyo-172 Strain Solution
  • Immunobladder

Other: Laboratory Biomarker Analysis
Correlative studies

Experimental: Arm III (Tokyo-172 strain BCG solution with priming)
PRIME: Patients receive Tokyo-172 strain BCG vaccine once ID. INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.
Biological: BCG Tokyo-172 Strain Solution
Given intravesically
Other Names:
  • Bacillus Calmette-Guerin Tokyo-172 Strain Solution
  • Immunobladder

Biological: BCG Tokyo-172 Strain Vaccine
Given ID
Other Name: Bacillus Calmette-Guerin Tokyo-172 Strain Vaccine

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. TTHGR for Arm I compared to Arm II [ Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years ]
    Time to High Grade Recurrence

  2. TTHGR for Arm II compared to Arm III [ Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years ]
    Time to High Grade Recurrence


Secondary Outcome Measures :
  1. Disease free rates [ Time Frame: At 6 months ]
    Rates of patients who are disease free at six months versus not



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091660


Contacts
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Contact: Veronica Garcia (210)614-8808 ext 1008 vgarcia@swog.org

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Locations
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United States, Arizona
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Mark D. Tyson         
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Mark D. Tyson         
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Kevin G. Chan         
Los Angeles County-USC Medical Center Suspended
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Site Public Contact    323-865-0451      
Principal Investigator: Siamak Daneshmand         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact    310-423-8965      
Principal Investigator: Amit Gupta         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Jennifer M. Suga         
UC Irvine Health/Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact    877-827-8839    ucstudy@uci.edu   
Principal Investigator: Cory Hugen         
Stanford Cancer Institute Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Eila C. Skinner         
Kaiser Permanente-South Sacramento Recruiting
Sacramento, California, United States, 95823
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Jennifer M. Suga         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Jennifer M. Suga         
Kaiser Permanente-Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Jennifer M. Suga         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    720-848-0650      
Principal Investigator: Janet E. Kukreja         
United States, Connecticut
Smilow Cancer Center/Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Patrick A. Kenney         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Patrick A. Kenney         
United States, District of Columbia
MedStar Washington Hospital Center Suspended
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: Paul L. Crispen         
Baptist MD Anderson Cancer Center Active, not recruiting
Jacksonville, Florida, United States, 32207
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Site Public Contact    800-679-0775    canceranswers@moffitt.org   
Principal Investigator: Scott M. Gilbert         
United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Site Public Contact    404-321-6111 ext 7632      
Principal Investigator: Wayne B. Harris         
United States, Hawaii
Hawaii Cancer Care - Savio Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-539-2273      
Principal Investigator: Charles O. Kim         
Hawaii Oncology Inc-Pali Momi Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-487-7447      
Principal Investigator: Charles O. Kim         
Pali Momi Medical Center Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-486-6000      
Principal Investigator: Charles O. Kim         
Hawaii Cancer Care Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-524-6115      
Principal Investigator: Charles O. Kim         
Hawaii Oncology Inc-POB I Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-532-0315      
Principal Investigator: Charles O. Kim         
Island Urology Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-536-2306    virginia@cc.hawaii.edu   
Principal Investigator: Charles O. Kim         
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-545-8548      
Principal Investigator: Charles O. Kim         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-522-4333      
Principal Investigator: Charles O. Kim         
University of Hawaii Cancer Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-586-2979      
Principal Investigator: Charles O. Kim         
Hawaii Oncology Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Site Public Contact    808-531-8521      
Principal Investigator: Charles O. Kim         
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact    208-381-2774    eslinget@slhs.org   
Principal Investigator: Gary E. Goodman         
Saint Alphonsus Cancer Care Center-Caldwell Recruiting
Caldwell, Idaho, United States, 83605
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute - Fruitland Recruiting
Fruitland, Idaho, United States, 83619
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Gary E. Goodman         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Gary E. Goodman         
Saint Alphonsus Medical Center-Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute - Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Gary E. Goodman         
Saint Luke's Mountain States Tumor Institute-Twin Falls Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Site Public Contact    208-381-8059    hallsc@slhs.org   
Principal Investigator: Gary E. Goodman         
United States, Illinois
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Joshua J. Meeks         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Michael Abern         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Vamsi K. Vasireddy         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Vamsi K. Vasireddy         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Vamsi K. Vasireddy         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact    708-226-4357      
Principal Investigator: Alex Gorbonos         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Site Public Contact    618-242-4600      
Principal Investigator: Jay W. Carlson         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Vamsi K. Vasireddy         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Vamsi K. Vasireddy         
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Michael A. O'Donnell         
United States, Kansas
University of Kansas Hospital-Westwood Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Eugene K. Lee         
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
LSU Healthcare Network / Metairie Multi-Specialty Clinic Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
Louisiana State University Health Science Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
Ochsner Medical Center Jefferson Active, not recruiting
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site Public Contact    318-813-1422    JRowel@lsuhsc.edu   
Principal Investigator: Kara N. Babaian         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Trinity J. Bivalacqua         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie G. Dib         
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Samuel D. Kaffenberger         
Henry Ford Cancer Institute-Downriver Recruiting
Brownstown, Michigan, United States, 48183
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
Henry Ford Macomb Hospital-Clinton Township Recruiting
Clinton Township, Michigan, United States, 48038
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
Henry Ford Medical Center-Fairlane Recruiting
Dearborn, Michigan, United States, 48126
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
Henry Ford Medical Center-Columbus Recruiting
Novi, Michigan, United States, 48377
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Elie G. Dib         
Henry Ford West Bloomfield Hospital Recruiting
West Bloomfield, Michigan, United States, 48322
Contact: Site Public Contact    313-916-3721    CTOResearch@hfhs.org   
Principal Investigator: Ding Wang         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Site Public Contact    417-269-4520      
Principal Investigator: Jay W. Carlson         
United States, Montana
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
United States, Nevada
Comprehensive Cancer Centers of Nevada - Henderson Recruiting
Henderson, Nevada, United States, 89052
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada-Horizon Ridge Recruiting
Henderson, Nevada, United States, 89052
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
OptumCare Cancer Care at Seven Hills Recruiting
Henderson, Nevada, United States, 89052
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada-Southeast Henderson Recruiting
Henderson, Nevada, United States, 89074
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Las Vegas Urology - Pebble Recruiting
Henderson, Nevada, United States, 89074
Contact: Site Public Contact       research@sncrf.org   
Principal Investigator: John A. Ellerton         
Las Vegas Urology - Pecos Recruiting
Las Vegas, Nevada, United States, 89074
Contact: Site Public Contact       research@sncrf.org   
Principal Investigator: John A. Ellerton         
Hope Cancer Care of Nevada Recruiting
Las Vegas, Nevada, United States, 89103
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Radiation Oncology Centers of Nevada Central Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Northwest Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Las Vegas Urology - Cathedral Rock Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site Public Contact       research@sncrf.org   
Principal Investigator: John A. Ellerton         
Las Vegas Urology - Smoke Ranch Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site Public Contact       research@smcrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Town Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada-Summerlin Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
OptumCare Cancer Care at Fort Apache Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Central Valley Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Bernard H. Bochner         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Qiang J. Li         
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Bernard H. Bochner         
Arnot Ogden Medical Center/Falck Cancer Center Active, not recruiting
Elmira, New York, United States, 14905
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Bernard H. Bochner         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Bernard H. Bochner         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Paul M. Barr         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Matthew E. Nielsen         
United States, Ohio
Indu and Raj Soin Medical Center Recruiting
Beavercreek, Ohio, United States, 45431
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Debasish Sundi         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Sanjay G. Patel         
Mercy Hospital Oklahoma City Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Site Public Contact    405-752-3402      
Principal Investigator: Jay W. Carlson         
United States, Oregon
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Site Public Contact    541-269-8392    cherie.cox@bayareahospital.org   
Principal Investigator: Gary E. Goodman         
Saint Alphonsus Medical Center-Ontario Recruiting
Ontario, Oregon, United States, 97914
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Jen-Jane Liu         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Site Public Contact    215-955-6084      
Principal Investigator: James R. Mark         
United States, South Carolina
Greenville Health System Cancer Institute-Laurens Recruiting
Clinton, South Carolina, United States, 29325
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Yair Lotan         
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0565
Contact: Site Public Contact    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Stephen B. Williams         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Seth P. Lerner         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-632-6789    askmdanderson@mdanderson.org   
Principal Investigator: Ashish M. Kamat         
UTMB Cancer Center at Victory Lakes Recruiting
League City, Texas, United States, 77573
Contact: Site Public Contact    800-917-8906      
Principal Investigator: Stephen B. Williams         
Audie L Murphy VA Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    877-469-5300      
Principal Investigator: Michael A. Liss         
University Hospital Active, not recruiting
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Robert S. Svatek         
United States, Utah
Farmington Health Center Recruiting
Farmington, Utah, United States, 84025
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: William T. Lowrance         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: William T. Lowrance         
South Jordan Health Center Recruiting
South Jordan, Utah, United States, 84009
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: William T. Lowrance         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Timothy C. Brand         
United States, Wisconsin
Marshfield Clinic-Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Medical Center-EC Cancer Center Active, not recruiting
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Site Public Contact    608-775-2385    cancerctr@gundersenhealth.org   
Principal Investigator: David E. Marinier         
Marshfield Clinic - Ladysmith Center Recruiting
Ladysmith, Wisconsin, United States, 54848
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Medical Center-Marshfield Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Medical Center-Rice Lake Active, not recruiting
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Stevens Point Center Recruiting
Stevens Point, Wisconsin, United States, 54482
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Clinic-Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert Svatek Southwest Oncology Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03091660     History of Changes
Other Study ID Numbers: S1602
NCI-2016-00451 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1602 ( Other Identifier: SWOG )
S1602 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://swog.org/Visitors/Download/Policies/Policy43.pdf

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Vaccines
BCG Vaccine
Pharmaceutical Solutions
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic