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Spots Global Cancer Trial Database for S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Robert Svatek

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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