Protocol Summary

Protocol No.: OCR15976

Sponsor Protocol No.: S1602

Study Title
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

Principal Investigator(s)
Crispen, Paul

Objective
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.

Description
Patients are randomized to 1 of 3 treatment arms.
After completion of study treatment, patients are followed up for 5 years.

Phase: Phase III

Age Group: Adult

Scope: National

Treatment
Arm I (BCG solution)
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 (Tokyo-172 strain BCG solution)
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 (Tokyo-172 strain BCG solution with priming)
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.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older
2. Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration
3. 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
4. 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 =5. Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification
6. Patients must not have pure squamous cell carcinoma or adenocarcinoma
7. Patients' disease must not have micropapillary components
8. 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
9. Patients must not have nodal involvement or metastatic disease
10. 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
11. Patients must have a Zubrod performance status of 0-2
12. Patients must not have received prior intravesical BCG
13. Patients must not have known history of tuberculosis
14. Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as 15. Patients must not be taking oral glucocorticoids at the time of registration
16. Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
17. Prestudy history and physical must be obtained within 90days prior to registration
18. 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
19. Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies

Applicable Disease Sites
Bladder Cancer

Participating Institutions
UF Gainesville : Mieniecia Black

Contact
Mieniecia Black
Phone: +1 352-265-0680 ext. 87658

Email: nblack@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT03091660