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.
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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | February 7, 2017 | Phase 3 | Interventional |
Primary Outcome 1 - Measure: TTHGR for Arm I compared to Arm II
Primary Outcome 1 - Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years
Primary Outcome 2 - Measure: TTHGR for Arm II compared to Arm III
Primary Outcome 2 - Time Frame: Time from randomization to first high grade recurrence assessed up to 5 years
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
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Gender: All
Minimum Age: N/A
Maximum Age: N/A
Healthy Volunteers: No
Name: Robert Svatek
Role: Principal Investigator
Affiliation: Southwest Oncology Group
Name: Nicki Trevino
Phone: (210)614-8808
Email: ntrevino@swog.org
Facility | Status | Contact |
---|---|---|
Mayo Clinic Hospital Phoenix, Arizona 85054 United States |
Recruiting |
Site Public Contact 855-776-0015 |
Mayo Clinic in Arizona Scottsdale, Arizona 85259 United States |
Recruiting |
Site Public Contact 855-776-0015 |
City of Hope Comprehensive Cancer Center Duarte, California 91010 United States |
Recruiting |
Site Public Contact 800-826-4673 becomingapatient@coh.org |
Los Angeles County-USC Medical Center Los Angeles, California 90033 United States |
Recruiting |
Site Public Contact 323-865-0451 |
USC / Norris Comprehensive Cancer Center Los Angeles, California 90033 United States |
Recruiting |
Site Public Contact 323-865-0451 |
Kaiser Permanente-Oakland Oakland, California 94611 United States |
Recruiting |
Site Public Contact 877-642-4691 Kpoct@kp.org |
Stanford Cancer Institute Palo Alto Palo Alto, California 94304 United States |
Recruiting |
Site Public Contact 650-498-7061 ccto-office@stanford.edu |
Kaiser Permanente-Vallejo Vallejo, California 94589 United States |
Recruiting |
Site Public Contact 877-642-4691 Kpoct@kp.org |
University of Colorado Hospital Aurora, Colorado 80045 United States |
Recruiting |
Site Public Contact 720-848-0650 |
MedStar Washington Hospital Center Washington, District of Columbia 20010 United States |
Recruiting |
Site Public Contact 202-877-8839 |
University of Florida Health Science Center - Gainesville Gainesville, Florida 32610 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Baptist MD Anderson Cancer Center Jacksonville, Florida 32207 United States |
Recruiting |
Site Public Contact 904-202-7051 |
Atlanta VA Medical Center Decatur, Georgia 30033 United States |
Recruiting |
Site Public Contact 404-321-6111 |
Saint Luke's Mountain States Tumor Institute Boise, Idaho 83712 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho 83619 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Saint Luke's Mountain States Tumor Institute - Meridian Meridian, Idaho 83642 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Saint Luke's Mountain States Tumor Institute - Nampa Nampa, Idaho 83686 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls, Idaho 83301 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Centralia Oncology Clinic Centralia, Illinois 62801 United States |
Recruiting |
Site Public Contact 217-876-4740 rhamrick@dmhhs.org |
Northwestern University Chicago, Illinois 60611 United States |
Recruiting |
Site Public Contact 312-695-1301 cancer@northwestern.edu |
Carle on Vermilion Danville, Illinois 61832 United States |
Recruiting |
Site Public Contact 800-446-5532 Research@carle.com |
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois 62526 United States |
Recruiting |
Site Public Contact 217-876-4740 rhamrick@dmhhs.org |
Decatur Memorial Hospital Decatur, Illinois 62526 United States |
Recruiting |
Site Public Contact 217-876-4740 rhamrick@dmhhs.org |
Carle Physician Group-Effingham Effingham, Illinois 62401 United States |
Recruiting |
Site Public Contact 800-446-5532 Research@carle.com |
Crossroads Cancer Center Effingham, Illinois 62401 United States |
Recruiting |
Site Public Contact 217-876-4740 rhamrick@dmhhs.org |
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois 61938 United States |
Recruiting |
Site Public Contact 800-446-5532 Research@carle.com |
Southern Illinois University School of Medicine Springfield, Illinois 62702 United States |
Recruiting |
Site Public Contact 217-545-7929 |
Springfield Clinic Springfield, Illinois 62702 United States |
Recruiting |
Site Public Contact 800-444-7541 |
Memorial Medical Center Springfield, Illinois 62781 United States |
Recruiting |
Site Public Contact 217-788-3528 |
Cancer Care Specialists of Illinois-Swansea Swansea, Illinois 62226 United States |
Recruiting |
Site Public Contact 217-876-4740 rhamrick@dmhhs.org |
Carle Cancer Center Urbana, Illinois 61801 United States |
Recruiting |
Site Public Contact 800-446-5532 Research@carle.com |
The Carle Foundation Hospital Urbana, Illinois 61801 United States |
Recruiting |
Site Public Contact 800-446-5532 Research@carle.com |
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas 66205 United States |
Recruiting |
Site Public Contact 913-945-7552 ctnursenav@kumc.edu |
East Jefferson General Hospital Metairie, Louisiana 70006 United States |
Recruiting |
Site Public Contact 504-210-3539 trials@jeffradonc.com |
Louisiana State University Health Science Center New Orleans, Louisiana 70112 United States |
Recruiting |
Site Public Contact 504-568-2428 emede1@lsuhsc.edu |
Ochsner Medical Center Jefferson New Orleans, Louisiana 70121 United States |
Recruiting |
Site Public Contact 504-703-8712 Gregory.Johnstone@ochsner.org |
Louisiana State University Health Sciences Center Shreveport Shreveport, Louisiana 71103 United States |
Recruiting |
Site Public Contact 318-813-1412 JRowel@lsuhsc.edu |
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan 48109 United States |
Recruiting |
Site Public Contact 800-865-1125 |
Henry Ford Cancer Institute?Downriver Brownstown, Michigan 48183 United States |
Recruiting |
Site Public Contact protocols@swog.org |
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan 48038 United States |
Recruiting |
Site Public Contact 313-916-1784 |
Henry Ford Medical Center-Fairlane Dearborn, Michigan 48126 United States |
Recruiting |
Site Public Contact 888-734-5322 |
Henry Ford Hospital Detroit, Michigan 48202 United States |
Recruiting |
Site Public Contact 313-916-1784 |
Henry Ford Medical Center-Columbus Novi, Michigan 48377 United States |
Recruiting |
Site Public Contact 888-734-5322 |
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan 48322 United States |
Recruiting |
Site Public Contact 888-734-5322 |
Saint Francis Medical Center Cape Girardeau, Missouri 63703 United States |
Recruiting |
Site Public Contact 573-334-2230 sfmc@sfmc.net |
Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana 59405 United States |
Recruiting |
Site Public Contact 406-969-6060 mccinfo@mtcancer.org |
Renown Regional Medical Center Reno, Nevada 89502 United States |
Recruiting |
Site Public Contact 702-384-0013 research@sncrf.org |
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey 07920 United States |
Recruiting |
Site Public Contact 212-639-7592 |
Memorial Sloan Kettering Commack Commack, New York 11725 United States |
Recruiting |
Site Public Contact 212-639-7592 |
Arnot Ogden Medical Center/Falck Cancer Center Elmira, New York 14905 United States |
Active, not recruiting | |
Memorial Sloan Kettering Westchester Harrison, New York 10604 United States |
Recruiting |
Site Public Contact 212-639-7592 |
Memorial Sloan Kettering Cancer Center New York, New York 10065 United States |
Recruiting |
Site Public Contact 212-639-7592 |
University of Rochester Rochester, New York 14642 United States |
Recruiting |
Site Public Contact 585-275-5830 |
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina 27599 United States |
Recruiting |
Site Public Contact 877-668-0683 cancerclinicaltrials@med.unc.edu |
Indu and Raj Soin Medical Center Beavercreek, Ohio 45431 United States |
Recruiting |
Site Public Contact 937-775-1350 som_dcop@wright.edu |
Kettering Medical Center Kettering, Ohio 45429 United States |
Recruiting |
Site Public Contact 937-775-1350 som_dcop@wright.edu |
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma 73104 United States |
Recruiting |
Site Public Contact 405-271-8777 ou-clinical-trials@ouhsc.edu |
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma 73120 United States |
Recruiting |
Site Public Contact 405-752-3402 |
Bay Area Hospital Coos Bay, Oregon 97420 United States |
Recruiting |
Site Public Contact 541-269-8392 cherie.cox@bayareahospital.org |
SWOG Portland, Oregon 97239 United States |
Recruiting |
Robert S. Svatek 210-567-6876 S1602question@swog.org |
Thomas Jefferson University Hospital Philadelphia, Pennsylvania 19107 United States |
Recruiting |
Site Public Contact 215-955-6084 |
Greenville Health System Cancer Institute-Laurens Clinton, South Carolina 29325 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Easley Easley, South Carolina 29640 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Butternut Greenville, South Carolina 29605 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Faris Greenville, South Carolina 29605 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Memorial Hospital Greenville, South Carolina 29605 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Eastside Greenville, South Carolina 29615 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Greer Greer, South Carolina 29650 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Seneca Seneca, South Carolina 29672 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
Greenville Health System Cancer Institute-Spartanburg Spartanburg, South Carolina 29307 United States |
Recruiting |
Site Public Contact 864-241-6251 kwilliams8@ghs.org |
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas 75390 United States |
Recruiting |
Site Public Contact 214-648-7097 canceranswerline@UTSouthwestern.edu |
University of Texas Medical Branch Galveston, Texas 77555-0565 United States |
Recruiting |
Site Public Contact 409-772-1950 clinical.research@utmb.edu |
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas 77030 United States |
Recruiting |
Site Public Contact 713-798-1354 burton@bcm.edu |
M D Anderson Cancer Center Houston, Texas 77030 United States |
Recruiting |
Site Public Contact 877-312-3961 |
UTMB Cancer Center at Victory Lakes League City, Texas 77573 United States |
Recruiting |
Site Public Contact 800-917-8906 |
Audie L Murphy Veterans Affairs Hospital San Antonio, Texas 78209 United States |
Recruiting |
Site Public Contact 877-469-5300 |
University Hospital San Antonio, Texas 78229 United States |
Recruiting |
Site Public Contact 210-358-4176 evelyn.swenson-britt@uhs-sa.com |
University of Texas Health Science Center at San Antonio San Antonio, Texas 78229 United States |
Recruiting |
Site Public Contact 210-450-3800 phoresearchoffice@uthscsa.edu |
Farmington Health Center Farmington, Utah 84025 United States |
Recruiting |
Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu |
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah 84112 United States |
Recruiting |
Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu |
South Jordan Health Center South Jordan, Utah 84009 United States |
Recruiting |
Site Public Contact 888-424-2100 cancerinfo@hci.utah.edu |
Madigan Army Medical Center Tacoma, Washington 98431 United States |
Recruiting |
Site Public Contact 253-968-0129 mamcdci@amedd.army.mil |
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin 54729 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic Cancer Center - Eau Claire Eau Claire, Wisconsin 54701 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Gundersen Lutheran Medical Center La Crosse, Wisconsin 54601 United States |
Recruiting |
Site Public Contact 608-775-2385 cancerctr@gundersenhealth.org |
Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin 54848 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic Marshfield, Wisconsin 54449 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin 54548 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic-Rice Lake Center Rice Lake, Wisconsin 54868 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic Stevens Point Center Stevens Point, Wisconsin 54482 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic-Wausau Center Wausau, Wisconsin 54401 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic - Weston Center Weston, Wisconsin 54476 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin 54494 United States |
Recruiting |
Site Public Contact 800-782-8581 oncology.clinical.trials@marshfieldresearch.org |