BCG Strains +/− Vaccine for Bladder Cancer

Not currently recruiting at 179 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: SWOG Cancer Research Network

Must not be taking: Oral glucocorticoids

Disqualifiers: Tuberculosis, Metastatic disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of BCG treatment for bladder cancer that hasn't spread to the muscle. BCG is a harmless bacterium that can help the immune system fight cancer when placed directly into the bladder. The trial compares a regular BCG solution to a Tokyo-172 strain BCG solution, with some participants also receiving a BCG Tokyo-172 strain vaccine to determine which is most effective in preventing cancer recurrence. Individuals with non-muscle invasive bladder cancer, who haven't received prior BCG treatments, and who have had visible tumors removed might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the Tokyo-172 strain of BCG, used both as a solution and a vaccine, is generally well-tolerated. Research indicates that the rate of side effects is similar between the Tokyo-172 strain and other BCG strains, suggesting comparable safety to other BCG treatments often used for bladder cancer.

Some studies report that the Tokyo-172 strain can cause mild reactions, such as soreness or irritation at the injection site. These reactions are common for BCG treatments and are usually not serious. However, like any medical treatment, there is a chance of side effects.

Overall, evidence suggests that the Tokyo-172 strain, both as a solution and a vaccine, is generally safe for treating bladder cancer. It is always important to discuss any concerns with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for bladder cancer because they explore different strains of the Bacillus Calmette-Guérin (BCG) vaccine, which might enhance effectiveness. Unlike the standard TICE BCG solution, the Tokyo-172 strain is being tested for its potential to boost the immune response against cancer cells. Additionally, one arm of the trial includes a priming phase with the Tokyo-172 BCG vaccine, which could further prepare the immune system to fight the cancer more effectively. These approaches could offer new hope for better outcomes in bladder cancer treatment by potentially increasing the body's ability to combat the disease.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Research has shown that the Tokyo-172 strain of BCG, a type of bacteria used to boost the immune system, may help reduce the recurrence of bladder cancer. In this trial, participants may receive the Tokyo-172 strain BCG solution, either with or without priming. One study found that this strain had the lowest recurrence rate, averaging 22%. Clinical trials reported that 62% of patients experienced a complete response to the Tokyo-172 strain, lasting over 47 months. Another study found that BCG Tokyo-172 was more effective at reducing cancer recurrence than chemotherapy. These findings suggest that this treatment might help prevent bladder cancer from returning. ^{1 2 4 6 7}

Who Is on the Research Team?

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.

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?

Group I: Arm III (Tokyo-172 strain BCG solution with priming) Experimental Treatment 3 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 Treatment 2 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 Control 2 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.

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Bacillus Calmette-Guerin for bladder cancer: A protocol of systematic review. Zhang, ZH., Yin, L., Zhang, LL., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical review of BCG vaccine in Japan. Yamamoto, S., Yamamoto, T.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10093360/

Efficacy of Different Bacillus of Calmette-Guérin (BCG) ... Overall, this was followed by BCG Tice (12.5%, 31.7%, and 32.4%) and BCG Tokyo 172 (21.9%, 15.7%, and 14.7%). These assumptions were further ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10064385/

Efficacy of Intravesical Instillation Therapy with Low-Dose ... Recurrence-free survival (RFS) in group A was significantly better for the Connaught strain than the low-dose Tokyo-172 strain (p = 0.026), but ...

3. mdpi.com mdpi.com/2227-9059/13/1/174

Comparison of BCG Tokyo172 Strain Induction Therapy ... Conclusions: In this study, we found that low-dose BCG induction therapy was associated with higher relapse rates compared with standard doses, especially in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022534717392467

Review Article Efficacy of bacillus Calmette-Guérin Strains ... Use of Tokyo-172, Pasteur and TICE strains resulted in a significant decrease in recurrence compared to chemotherapy. However, no BCG strain was significantly ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1078143923001187

The efficacy and safety outcomes of lower dose BCG ... This study aimed to assess both efficacy and safety outcomes of lowering the dose of BCG compared to intravesical chemotherapies in non–muscle-invasive bladder ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03091660

S1602: Different Strains of BCG With or Without Vaccine in ... This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23376145/

A prospective comparative study of intravesical bacillus ... Results suggest no significant differences between the Tokyo and Connaught strains in the complete response, recurrence-free survival or adverse event rate.