Different Versions of BCG with or without Vaccine Therapy in Treating Patients with High Grade Bladder Cancer That is Not Muscle Invasive

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and overS1602
NCI-2016-00451, NCT03091660

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

SWOG

  • National Cancer Institute
Robert Scott Svatek, Principal Investigator

Trial Sites

U.S.A.

Illinois
Centralia

Centralia Oncology Clinic

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur

Cancer Care Center of Decatur

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Decatur Memorial Hospital

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Effingham

Crossroads Cancer Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Louisiana
Metairie

East Jefferson General Hospital

Augusto C. Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Augusto C. Ochoa
Principal Investigator

New Orleans

Louisiana State University Health Science Center

Augusto C. Ochoa
Ph: 504-568-2428
Email: emede1@lsuhsc.edu

Augusto C. Ochoa
Principal Investigator

Ochsner Medical Center Jefferson

Daniel James Canter
Ph: 504-842-3708

Daniel James Canter
Principal Investigator

Michigan
Ann Arbor

University of Michigan Comprehensive Cancer Center

Ajjai Shivaram Alva
Ph: 800-865-1125

Ajjai Shivaram Alva
Principal Investigator

Brownstown

Henry Ford Cancer Institute¿Downriver

Robert Anthony Chapman
Ph: 313-916-1784

Robert Anthony Chapman
Principal Investigator

Clinton Township

Henry Ford Macomb Hospital-Clinton Township

Robert Anthony Chapman
Ph: 313-916-1784

Robert Anthony Chapman
Principal Investigator

Dearborn

Henry Ford Medical Center-Fairlane

Robert Anthony Chapman
Ph: 313-916-1784

Robert Anthony Chapman
Principal Investigator

Detroit

Henry Ford Hospital

Robert Anthony Chapman
Ph: 313-916-1784

Robert Anthony Chapman
Principal Investigator

West Bloomfield

Henry Ford West Bloomfield Hospital

Robert Anthony Chapman
Ph: 313-916-1784

Robert Anthony Chapman
Principal Investigator

Missouri
Cape Girardeau

Saint Francis Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Montana
Great Falls

Benefis Healthcare- Sletten Cancer Institute

Benjamin T. Marchello
Ph: 800-648-6274

Benjamin T. Marchello
Principal Investigator

New York
Elmira

Arnot Ogden Medical Center/Falck Cancer Center

Alan H. Angell
Ph: 607-271-7000

Alan H. Angell
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Sanjay G. Patel
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Sanjay G. Patel
Principal Investigator

Oregon
Coos Bay

Bay Area Hospital

Gary E. Goodman
Ph: 206-215-3086
Email: PCRC-NCORP@Swedish.org

Gary E. Goodman
Principal Investigator

Portland

SWOG

Robert Scott Svatek
Ph: 210-567-6876
Email: S1602question@swog.org

Robert Scott Svatek
Principal Investigator

Texas
San Antonio

University Hospital

Robert Scott Svatek
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Robert Scott Svatek
Principal Investigator

University of Texas Health Science Center at San Antonio

Robert Scott Svatek
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Robert Scott Svatek
Principal Investigator

Utah
Salt Lake City

Huntsman Cancer Institute/University of Utah

William Thomas Lowrance
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

William Thomas Lowrance
Principal Investigator

South Jordan

South Jordan Health Center

William Thomas Lowrance
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

William Thomas Lowrance
Principal Investigator

Wisconsin
La Crosse

Gundersen Lutheran Medical Center

David E. Marinier
Ph: 608-775-2385
Email: cancerctr@gundersenhealth.org

David E. Marinier
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT03091660

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.