1000 Participants Needed

BCG Strains +/− Vaccine for Bladder Cancer

Recruiting at 173 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: SWOG Cancer Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take oral glucocorticoids or plan to receive other cancer therapies while on the study.

Is the BCG vaccine safe for use in bladder cancer treatment?

The BCG vaccine, including the Tokyo-172 strain, has been used safely in bladder cancer treatment, but some side effects like frequent urination, pain during urination, and fever have been reported. These side effects are generally manageable and are similar to those seen with other BCG strains used for bladder cancer.12345

How does the BCG Tokyo-172 strain treatment for bladder cancer differ from other treatments?

The BCG Tokyo-172 strain treatment for bladder cancer is unique because it uses a low-dose intravesical (directly into the bladder) instillation of the BCG vaccine, which has shown effectiveness in reducing tumor recurrence with minimal side effects compared to other strains. This approach is particularly notable for its use in maintenance therapy and its potential for fewer bladder irritability symptoms.13678

What data supports the effectiveness of the BCG Tokyo-172 strain treatment for bladder cancer?

Research shows that the BCG Tokyo-172 strain is effective in treating superficial bladder cancer, with 66.4% of patients experiencing complete tumor disappearance and 20.8% having partial disappearance. Additionally, 84.4% of patients with carcinoma in situ (a very early stage of cancer) showed complete disappearance of the cancer.13569

Who Is on the Research Team?

RS

Robert Svatek

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

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.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prime

Patients receive Tokyo-172 strain BCG vaccine once intradermally

1 day
1 visit (in-person)

Induction

Patients receive BCG solution intravesically once a week for 6 weeks

6 weeks
6 visits (in-person)

Maintenance

Patients receive BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36

Up to 36 months
21 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • BCG Solution
  • BCG Tokyo-172 Strain Solution
  • BCG Tokyo-172 Strain Vaccine
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Recruited
267,000+

Southwest Oncology Group

Lead Sponsor

Trials
389
Recruited
260,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

This study aims to systematically evaluate the efficacy and safety of Bacillus Calmette-Guerin (BCG) treatment for bladder cancer by reviewing high-quality trials from various databases, ensuring a comprehensive analysis.
The findings will provide crucial evidence to determine the effectiveness of BCG in treating bladder cancer, potentially influencing treatment decisions for patients.
Efficacy and safety of Bacillus Calmette-Guerin for bladder cancer: A protocol of systematic review.Zhang, ZH., Yin, L., Zhang, LL., et al.[2023]
In a study of 114 patients with non-muscle invasive bladder cancer, the BCG Danish 1331 strain showed a significantly lower incidence of moderate to severe adverse events compared to the BCG Moscow-I strain, indicating it may be a safer option for treatment.
Both strains demonstrated similar efficacy in terms of 3-year recurrence-free survival (80.0% for Danish 1331 vs. 72.9% for Moscow-I) and progression-free survival (96.5% for Danish 1331 vs. 97.8% for Moscow-I), suggesting that while safety profiles differ, their effectiveness in preventing cancer recurrence is comparable.
Intravesical bacillus Calmette-Guerin (BCG) in treating non-muscle invasive bladder cancer-analysis of adverse effects and effectiveness of two strains of BCG (Danish 1331 and Moscow-I).Thyavihally, YB., Dev, P., Waigankar, S., et al.[2022]
The Tokyo-172 strain of the BCG vaccine, developed in Japan from the 172nd passage of the original culture, has been recognized as an International Reference Strain by the World Health Organization since 1965, highlighting its importance in vaccine research and standardization.
The introduction of a multiple puncture method for BCG vaccination in 1967 improved the administration technique, making it safer and more effective compared to traditional intradermal injections, while ongoing research continues to evaluate its efficacy and potential adverse reactions.
Historical review of BCG vaccine in Japan.Yamamoto, S., Yamamoto, T.[2022]

Citations

Comparable effect with minimal morbidity of low-dose Tokyo 172 strain compared with regular dose Connaught strain as an intravesical bacillus Calmette-Guérin prophylaxis in nonmuscle invasive bladder cancer: Results of a randomized prospective comparison. [2021]
[Ablative and prophylactic effects of BCG Tokyo 172 strain for intravesical treatment in patients with superficial bladder cancer and carcinoma in situ of the bladder. Bladder cancer BCG Study Group]. [2019]
Impact of maintenance therapy using a half dose of the bacillus Calmette-Guérin Tokyo strain on recurrence of intermediate and high-risk nonmuscle invasive bladder cancer: a retrospective single-center study. [2021]
Efficacy and safety of Bacillus Calmette-Guerin for bladder cancer: A protocol of systematic review. [2023]
Intravesical bacillus Calmette-Guerin (BCG) in treating non-muscle invasive bladder cancer-analysis of adverse effects and effectiveness of two strains of BCG (Danish 1331 and Moscow-I). [2022]
[ImmuCyst intravesical (freeze-dried preparation made from the connaught strain of Bacillus Calmette Guérin) for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder]. [2013]
Historical review of BCG vaccine in Japan. [2022]
Intravesical Bacillus Calmette-Guérin treatment for superficial bladder tumours. [2019]
[Treatment of patients with recurrent superficial bladder cancer with lyophilized Moureau-Rio de Janeiro BCG strain. Brazillian National Cancer Institute experience]. [2006]
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