S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma
About this trial
This is an interventional treatment trial for Stage 0 Bladder Urothelial Carcinoma
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
Sites / Locations
- University of South Alabama Mitchell Cancer Institute
- Banner MD Anderson Cancer Center
- Mayo Clinic Hospital in Arizona
- Mayo Clinic in Arizona
- City of Hope Comprehensive Cancer Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Kaiser Permanente-Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-South Sacramento
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- University of Colorado Hospital
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- MedStar Washington Hospital Center
- George Washington University Medical Center
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer Center
- Moffitt Cancer Center - McKinley Campus
- Moffitt Cancer Center
- Atlanta VA Medical Center
- Hawaii Cancer Care - Savio
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- Island Urology-Hilo
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Cancer Institute - Nampa
- Saint Luke's Cancer Institute - Twin Falls
- Centralia Oncology Clinic
- Northwestern University
- University of Illinois
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- Cancer Care Center of O'Fallon
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- University of Kansas Hospital-Westwood Cancer Center
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Brigham and Women's Hospital
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford Hospital
- Sparrow Hospital
- Henry Ford Medical Center-Columbus
- Saint John Macomb-Oakland Hospital
- Henry Ford West Bloomfield Hospital
- Saint Francis Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- Benefis Healthcare- Sletten Cancer Institute
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- OptumCare Cancer Care at Oakey
- Hope Cancer Care of Nevada
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Comprehensive Cancer Centers of Nevada - Northwest
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- Urology Specialists of Nevada - Southwest
- Comprehensive Cancer Centers of Nevada - Central Valley
- Renown Regional Medical Center
- Memorial Sloan Kettering Basking Ridge
- Englewood Hospital and Medical Center
- Memorial Sloan Kettering Monmouth
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Arnot Ogden Medical Center/Falck Cancer Center
- Memorial Sloan Kettering Westchester
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- State University of New York Upstate Medical University
- Memorial Sloan Kettering Nassau
- UNC Lineberger Comprehensive Cancer Center
- Indu and Raj Soin Medical Center
- Ohio State University Comprehensive Cancer Center
- Kettering Medical Center
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Bay Area Hospital
- Rogue Valley Medical Center
- Saint Alphonsus Medical Center-Ontario
- Oregon Health and Science University
- Portland VA Medical Center
- Thomas Jefferson University Hospital
- Prisma Health Cancer Institute - Spartanburg
- Ralph H Johnson VA Medical Center
- Prisma Health Cancer Institute - Laurens
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Houston Methodist Hospital
- M D Anderson Cancer Center
- UTMB Cancer Center at Victory Lakes
- Audie L Murphy VA Hospital
- University Hospital
- University of Texas Health Science Center at San Antonio
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- Fred Hutchinson Cancer Research Center
- Seattle Cancer Care Alliance
- University of Washington Medical Center - Montlake
- Madigan Army Medical Center
- West Virginia University Healthcare
- Marshfield Clinic-Chippewa Center
- Marshfield Medical Center-EC Cancer Center
- Gundersen Lutheran Medical Center
- Marshfield Clinic - Ladysmith Center
- Marshfield Medical Center-Marshfield
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Marshfield Medical Center-Rice Lake
- Marshfield Clinic Stevens Point Center
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (BCG solution)
Arm II (Tokyo-172 strain BCG solution)
Arm III (Tokyo-172 strain BCG solution with priming)
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.
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.
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.