BCG Strains +/− Vaccine for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+173 other locations

Overseen byRobert Svatek

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing two versions of a treatment called BCG, which uses bacteria to help the immune system fight bladder cancer. It focuses on patients whose bladder cancer has not spread to the muscle. The treatment aims to prevent the cancer from returning by boosting the body's natural defenses. BCG has been used for a long time as an effective treatment for non-muscle-invasive bladder cancer, helping to prevent recurrences and tumor progression.

Eligibility Criteria

This trial is for adults with high-grade non-muscle invasive bladder cancer, who've had all visible tumors removed and show no signs of metastatic disease. They must not have received prior BCG therapy or have a history of tuberculosis, and should be in good physical condition (Zubrod status 0-2). Pregnant or nursing individuals are excluded, as well as those unwilling to use contraception.

Inclusion Criteria

All visible tumors were removed or confirmed absent by a doctor within the last 30 days.

My scans show no signs of cancer spread and recent surgery confirms my cancer is still early stage.

My cancer does not have micropapillary features.

+16 more

Participant Groups

The study compares the effectiveness of two BCG treatments for bladder cancer: Tokyo-172 strain solution alone versus combined with a vaccine. The goal is to see which method better prevents the return of cancer after treatment by stimulating the immune system.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (Tokyo-172 strain BCG solution with priming)Experimental Treatment3 Interventions

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.

Group II: Arm II (Tokyo-172 strain BCG solution)Experimental Treatment2 Interventions

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.

Group III: Arm I (BCG solution)Active Control2 Interventions

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.