Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT03091660

Recruitment Status:

Active, not recruiting

Sponsor:

SWOG Cancer Research Network

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There are 135 Locations for this study

See Locations Near You

University of South Alabama Mitchell Cancer Institute
Mobile Alabama, 36688, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Mayo Clinic Hospital in Arizona
Phoenix Arizona, 85054, United States
Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Los Angeles County-USC Medical Center
Los Angeles California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
Kaiser Permanente-South Sacramento
Sacramento California, 95823, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
Kaiser Permanente-Vallejo
Vallejo California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek California, 94596, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven Connecticut, 06510, United States
Yale University
New Haven Connecticut, 06520, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
George Washington University Medical Center
Washington District of Columbia, 20037, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Moffitt Cancer Center - McKinley Campus
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Atlanta VA Medical Center
Decatur Georgia, 30033, United States
Hawaii Cancer Care - Savio
'Aiea Hawaii, 96701, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Queen's Cancer Center - Pearlridge
'Aiea Hawaii, 96701, United States
Island Urology-Hilo
Hilo Hawaii, 96720, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Island Urology
Honolulu Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States
Queen's Cancer Center - Kuakini
Honolulu Hawaii, 96817, United States
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian Idaho, 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa Idaho, 83686, United States
Saint Luke's Cancer Institute - Nampa
Nampa Idaho, 83686, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls Idaho, 83301, United States
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Illinois
Chicago Illinois, 60612, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon Illinois, 62864, United States
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Springfield Clinic
Springfield Illinois, 62702, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
East Jefferson General Hospital
Metairie Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
LSU Health Sciences Center at Shreveport
Shreveport Louisiana, 71103, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Henry Ford Cancer Institute-Downriver
Brownstown Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Henry Ford Medical Center-Columbus
Novi Michigan, 48377, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Henry Ford West Bloomfield Hospital
West Bloomfield Michigan, 48322, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas Nevada, 89074, United States
OptumCare Cancer Care at Oakey
Las Vegas Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas Nevada, 89103, United States
Radiation Oncology Centers of Nevada Central
Las Vegas Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas Nevada, 89106, United States
Las Vegas Prostate Cancer Center
Las Vegas Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas Nevada, 89113, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States
Urology Specialists of Nevada - Southwest
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas Nevada, 89169, United States
Renown Regional Medical Center
Reno Nevada, 89502, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States
Englewood Hospital and Medical Center
Englewood New Jersey, 07631, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira New York, 14905, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Indu and Raj Soin Medical Center
Beavercreek Ohio, 45431, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City Oklahoma, 73120, United States
Bay Area Hospital
Coos Bay Oregon, 97420, United States
Rogue Valley Medical Center
Medford Oregon, 97504, United States
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Portland VA Medical Center
Portland Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
Ralph H Johnson VA Medical Center
Charleston South Carolina, 29401, United States
Prisma Health Cancer Institute - Laurens
Clinton South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
UTMB Cancer Center at Victory Lakes
League City Texas, 77573, United States
Audie L Murphy VA Hospital
San Antonio Texas, 78229, United States
University Hospital
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Farmington Health Center
Farmington Utah, 84025, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
South Jordan Health Center
South Jordan Utah, 84009, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
Marshfield Clinic - Ladysmith Center
Ladysmith Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Marshfield Clinic Stevens Point Center
Stevens Point Wisconsin, 54482, United States
Marshfield Clinic-Wausau Center
Wausau Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids Wisconsin, 54494, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1000

Study ID:

NCT03091660

Recruitment Status:

Active, not recruiting

Sponsor:


SWOG Cancer Research Network

How clear is this clinincal trial information?

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