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BRIEF 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

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


  • Org Study ID: S1602
  • Secondary ID: NCI-2016-00451,S1602,S1602,U10CA180888
  • NCT ID: NCT03091660
  • NCT Alias:
  • Sponsor: Southwest Oncology Group - Other
  • Source: Southwest Oncology Group

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.

Overal Status Start Date Phase Study Type
Recruiting February 7, 2017 Phase 3 Interventional

Primary Outcomes:

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

Condition:

  • Stage 0 Bladder Urothelial Carcinoma
  • Stage 0is Bladder Urothelial Carcinoma
  • Stage I 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
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Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Robert Svatek

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Overall Contact

Name: Nicki Trevino

Phone: (210)614-8808

Email: ntrevino@swog.org

Locations

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