BCG Strains +/− Vaccine for Bladder Cancer
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prime
Patients receive Tokyo-172 strain BCG vaccine once intradermally
Induction
Patients receive BCG solution intravesically once a week for 6 weeks
Maintenance
Patients receive BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BCG Solution
- BCG Tokyo-172 Strain Solution
- BCG Tokyo-172 Strain Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator