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Cancer Vaccine
BCG Strains +/− Vaccine for Bladder Cancer
Phase 3
Waitlist Available
Led By Robert Svatek
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration
Patients must be >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to first high grade recurrence assessed up to 5 years
Awards & highlights
Study Summary
This trial studies two versions of BCG to treat bladder cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
BCG treatment can cause flu-like symptoms, irritation in the bladder area, low-grade fever, and fatigue. Rarely it may lead to more serious side effects like an allergic reaction or impact on liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show no signs of cancer spread and recent surgery confirms my cancer is still early stage.
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I am 18 years old or older.
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My bladder cancer is classified as high-grade.
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My cancer is not purely squamous cell or adenocarcinoma.
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My cancer does not have micropapillary features.
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My cancer has not spread to my lymph nodes or other parts of my body.
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I have never had tuberculosis.
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I am not planning to undergo any other cancer treatments while participating in this study.
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I have never had BCG treatment directly into my bladder.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I am not taking oral glucocorticoids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization to first high grade recurrence assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to first high grade recurrence assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
TTHGR for Arm I compared to Arm II
TTHGR for Arm II compared to Arm III
Secondary outcome measures
Disease free rates
Trial Design
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 Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,170 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,153 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,811 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have no signs of cancer in my upper urinary tract as confirmed by a recent test.My cancer has not spread to my lymph nodes or other parts of my body.I have no cancer history except for certain treated cancers or cancers in remission for 5+ years.I have never had tuberculosis.I am not planning to undergo any other cancer treatments while participating in this study.I am not pregnant or nursing and will use effective birth control or remain abstinent.I am 18 years old or older.You should have a negative PPD test result within 90 days before joining the study. A negative result means the raised area on your arm should be less than 10 mm after a standard tuberculosis skin test.My bladder cancer was confirmed by a lab test within the last 3 months.My bladder cancer is classified as high-grade.My cancer is not purely squamous cell or adenocarcinoma.I have never had BCG treatment directly into my bladder.I can take care of myself and am up and about more than 50% of my waking hours.I had a physical exam within the last 3 months.I am not taking oral glucocorticoids.
Research Study Groups:
This trial has the following groups:- Group 1: Arm III (Tokyo-172 strain BCG solution with priming)
- Group 2: Arm I (BCG solution)
- Group 3: Arm II (Tokyo-172 strain BCG solution)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you give an estimate of how many people are included in this experiment?
"This clinical trial is not actively recruiting patients at the moment. The study was originally posted on February 7th, 2017 and was last updated on March 8th, 2022. There are presently 2806 trials actively searching for patients with urinary bladder and 9 studies for BCG Tokyo-172 Strain Solution actively searching for participants."
Answered by AI
Is this clinical trial prominent in North American hospitals?
"As of now, there are 100 hospitals and medical facilities across the country participating in this study. Some notable locations include Mayo Clinic Hospital in Arizona, Stanford Cancer Institute Palo Alto, and Banner MD Anderson Cancer Center in Gilbert."
Answered by AI
Has BCG Tokyo-172 Strain Solution undergone FDA approval?
"There is some evidence of efficacy and several rounds of safety data, so BCG Tokyo-172 Strain Solution was given a safety score of 3."
Answered by AI
Are there any enrollees still needed for this experiment?
"This particular clinical trial is not currently looking for more patients, as the study has already wrapped up recruitment. However, there are presently 2806 clinical trials actively admitting patients with urinary bladder and 9 trials for BCG Tokyo-172 Strain Solution that are still enrolling participants."
Answered by AI
What is BCG Tokyo-172 Strain Solution's purpose?
"BCG Tokyo-172 Strain Solution is used for the prevention of stage t1 papillary tumors following transurethral resection. It is also indicated for use in patients with urinary bladder, prophylaxis of ta papillary tumors following transurethral resection, and prophylaxis of carcinoma in situ of the urinary bladder."
Answered by AI
Could you please list other research studies that have used BCG Tokyo-172 Strain Solution?
"BCG Tokyo-172 Strain Solution was first studied in 2013 at Concord Repatriation General Hospital. There have since been a total of 570 completed trials. Currently, there are 9 active clinical trials, several of which are based in Phoenix, Arizona."
Answered by AI
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