Study on Different BCG Strains with or without Vaccine for High-Grade Non-Muscle Invasive Bladder Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT03091660
This clinical trial is exploring whether different strains of BCG, a type of bacteria used to stimulate the immune system, can help treat bladder cancer that hasn't spread to the muscle. The study compares the effectiveness of Tokyo-172 strain BCG with or without a vaccine to the TICE BCG strain.
Patient Parameters
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Program Overview
This study is testing if using different strains of BCG, a non-infectious bacteria, can help prevent bladder cancer from returning. BCG is placed directly into the bladder to boost the immune system's ability to fight cancer. The trial compares the Tokyo-172 strain of BCG, with or without a vaccine, to the TICE BCG strain in patients with bladder cancer that hasn't spread to the muscle.
Description
The study has three main groups:
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Group 1 (Arm I): Patients receive TICE BCG solution directly into the bladder once a week for 6 weeks. They continue with maintenance doses once a week for 3 weeks at months 3, 6, 12, 18, 24, 30, and 36.
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Group 2 (Arm II): Patients receive Tokyo-172 strain BCG solution directly into the bladder once a week for 6 weeks. Maintenance doses are the same as in Group 1.
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Group 3 (Arm III): Patients first receive a Tokyo-172 strain BCG vaccine under the skin. Within 21 days, they start receiving the Tokyo-172 strain BCG solution directly into the bladder, following the same schedule as Group 2.
The study aims to see if the Tokyo-172 strain is as effective as the TICE strain and if adding a vaccine improves results. Patients are monitored for 5 years after treatment to track cancer recurrence and overall health.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of bladder cancer (Ta, CIS, or T1 stage) within the last 90 days.
- All visible tumors must have been removed or confirmed absent within 30 days before joining the study.
- For T1 stage, imaging tests must show no cancer spread, and a re-check must confirm T1 or less stage within 90 days.
- Must have high-grade bladder cancer as per specific medical guidelines.
- No pure squamous cell carcinoma or adenocarcinoma.
- No micropapillary components in the cancer.
- No cancer in the upper urinary tract confirmed by specific imaging tests within 90 days.
- No cancer spread to lymph nodes or other parts of the body.
- No other recent cancers, except for certain skin cancers or early-stage cancers in remission.
- Must have a performance status score of 0-2, indicating good overall health.
- No prior BCG treatment in the bladder.
- No history of tuberculosis and must test negative for it within 90 days.
- Must be 18 years or older.
- Not taking oral steroids at the time of joining.
- Not planning to receive other cancer treatments while in the study.
- Must not be pregnant or nursing and agree to use effective birth control if of reproductive potential.
- Must be willing to participate in specimen banking for future research.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles County-USC Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Kaiser Permanente-Oakland | 94611 | Oakland | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
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