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Brief Title: S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
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
Study ID: NCT03091660
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.
Detailed Description: PRIMARY OBJECTIVES: I. To compare whether time to high grade recurrence (TTHGR) for patients with BCG-naïve, non-muscle invasive bladder cancer (NMIBC) receiving Tokyo-172 BCG strain (Arm II) is non-inferior to patients receiving TICE BCG strain (Arm I). II. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation (Arm III) is superior to patients receiving intravesical Tokyo-172BCG instillation without prior intradermal BCG vaccination (Arm II). SECONDARY OBJECTIVES: I. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between patients receiving Tokyo-172 versus TICE BCG strain. II. To compare TTR with AG bladder cancer between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. III. To compare progression-free survival (PFS) between patients receiving Tokyo-172 versus TICE BCG strain. IV. To compare PFS between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. V. To compare 6-month complete response in patients with carcinoma in situ (CIS) with or without Ta or T1 cancer present at baseline receiving Tokyo-172 versus TICE BCG strain. VI. To compare 6-month complete response in patients with CIS with or without Ta or T1 cancer present at baseline receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. TERTIARY OBJECTIVES: I. To test the hypothesis that purified protein derivative (PPD) test conversion (positive PPD at 3 or 6 months) following BCG immunotherapy will predict time to high grade recurrence (TTHGR). II. To test the hypothesis that urinary cytokine levels following BCG immunotherapy will predict time to high grade recurrence (TTHGR). III. To test the hypothesis that tumor neoantigen burden and T lymphocyte infiltration are associated with BCG response. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: 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. ARM II: 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. ARM III: PRIME: Patients receive Tokyo-172 strain BCG vaccine once intradermally (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. After completion of study treatment, patients are followed up for 5 years.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, District of Columbia, United States
George Washington University Medical Center, Washington, 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
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
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
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 Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, 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, Las Vegas, Nevada, United States
OptumCare Cancer Care at Oakey, Las Vegas, Nevada, United States
Hope Cancer Care of Nevada, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
Urology Specialists of Nevada - Central, Las Vegas, Nevada, United States
Las Vegas Prostate Cancer Center, Las Vegas, Nevada, United States
Las Vegas Urology - Sunset, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock, Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch, Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView, Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Arnot Ogden Medical Center/Falck Cancer Center, Elmira, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Indu and Raj Soin Medical Center, Beavercreek, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Bay Area Hospital, Coos Bay, Oregon, United States
Rogue Valley Medical Center, Medford, Oregon, United States
Saint Alphonsus Medical Center-Ontario, Ontario, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Portland VA Medical Center, Portland, Oregon, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Ralph H Johnson VA Medical Center, Charleston, South Carolina, United States
Prisma Health Cancer Institute - Laurens, Clinton, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
Audie L Murphy VA Hospital, San Antonio, Texas, United States
University Hospital, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Farmington Health Center, Farmington, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
South Jordan Health Center, South Jordan, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Name: Robert Svatek
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR