S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Disease Related 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.

Prior/Concurrent Therapy Criteria:

  • Patients must not have received prior intravesical BCG or intradermal BCG.
  • 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.

Clinical/Laboratory Criteria:

  • Patients must not have known history of tuberculosis.
  • Patients must be negative for prior Tuberculosis infection as determined by a negative PPD test. If PPD is not available, then a negative Interferon Gamma Release Assay (IGRA) may be used. The PPD or IGRA test results must be obtained 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). For PPD readings done outside of 48-72 hour window, patients must have PPD test and reading repeated to confirm eligibility. IGRA positive is defined by the laboratory interpretation or using the package insert cut-off values. Any IGRA approved by the FDA is allowed, including the QuantiFERON®–TB Gold In-Tube test (QFT–GIT) or the T–SPOT® TB test (T–Spot).
  • Patients must be ≥ 18 years of age.
  • Prestudy history and physical must be obtained within 90 days prior to registration. Patients must have a complete blood count (CBC) and basic metabolic panel including creatinine, potassium, chloride, BUN, CO2 and glucose within 28 days 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.

Specimen Submission Criteria:

  • Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies.

Patient Reported Outcomes (PRO) Submission Criteria:

  • Patients who can complete PRO forms in English or Spanish must complete the baseline Bladder Cancer Index, EORTC QLQ-C30, AUASS, and Cancer Patient Tobacco Use Questionnaire forms.

Regulatory Criteria:

  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Site Criteria:

  • Treating physician must confirm availability and access to Intravesical BCG LIVE (TICE® BCG).
  • All operative, pathology, cytology and imaging reports needed to confirm eligibility and assess disease while patient is on study must be available in English to upload as a source document in RAVE.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Lyon, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Tyson, M.D., M.P.H.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20396302

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