40 Participants NeededMy employer runs this trial

BCG Treatment for Bladder Cancer

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 explores whether patient positioning during bladder cancer treatment with BCG affects the duration the medication stays in the bladder. BCG is a common treatment for non-muscle invasive bladder cancer. Researchers aim to determine if sitting, lying down, or having no restrictions can enhance its effectiveness by prolonging its presence in the bladder. This study is particularly relevant for patients with limited bladder capacity or severe urinary symptoms. Ideal participants include those with intermediate or high-risk bladder cancer who have not started BCG treatment and can maintain different positions for up to two hours. Participants will wear a fitness tracker to monitor activity. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for BCG Solution?

Research has shown that Bacillus Calmette-Guerin (BCG) therapy is generally safe for treating bladder cancer that hasn't spread into the muscle. Studies have found that BCG treatment reduces the chances of cancer recurrence or progression. Patients typically tolerate BCG well, especially compared to treatments like anti-PD-1/PD-L1 therapies, which often cause more side effects.

However, over 70% of patients experience some side effects, such as mild bladder irritation or flu-like symptoms. Serious side effects are less common, occurring in about 8% of patients, who might need to stop treatment as a result. Despite these potential effects, BCG remains a crucial treatment for bladder cancer, particularly after surgery, to help prevent recurrence.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the BCG treatment for bladder cancer because it explores different patient positions during treatment, which is not standard in current care. While standard BCG therapy involves intravesical administration without specific positional guidance, this trial investigates whether lying down or sitting might enhance treatment efficacy. Additionally, the use of a Fitbit activity tracker provides new data on how physical activity post-treatment might impact outcomes, offering fresh insights that could refine future bladder cancer therapies.

What is the effectiveness track record for BCG treatment for bladder cancer?

Research has shown that the Bacillus Calmette-Guérin (BCG) vaccine effectively treats a type of bladder cancer that hasn't spread into the muscle. Studies consistently find that BCG reduces the chance of cancer recurrence and helps prevent progression. Specifically, BCG treatment can eliminate cancer in about 70% of patients with carcinoma in situ, a cancer confined to the bladder lining. It is considered the best treatment for this type of bladder cancer. However, about 40% of patients may still experience cancer recurrence after treatment. Despite this, BCG remains the most effective option for patients at high risk. In this trial, participants will receive BCG treatment with different post-treatment activity guidance to evaluate its impact on treatment effectiveness.16789

Who Is on the Research Team?

CT

Cheryl T Lee, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with intermediate or high-risk non-muscle invasive bladder cancer who have not started BCG treatment. Participants must be able to stay lying down or sitting for two hours, use a fitness tracker for five days, and take part in remote visits.

Inclusion Criteria

I have not started induction therapy.
I can lie on my back for two hours with my head on up to two pillows.
* Willingness to utilize a wearable fitness tracker for at least five days during the study
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care BCG therapy once a week with different positioning instructions for each session

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Monitoring

Participants wear a Fitbit activity tracker to monitor vitals and mobility throughout the study

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BCG Solution

Trial Overview

The study looks at whether the way patients position themselves and how long they keep BCG medicine in their bladder affects treatment results. It uses activity trackers, surveys, medical record reviews, and standard BCG therapy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (BCG no restrictions, BCG lying down, BCG sitting)Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Citations

Outcomes of intravesical Bacillus Calmette-Guerin in patients ...

Several meta-analyses have shown that intravesical BCG therapy significantly reduces the risk of tumor recurrence in patients with NMIBC, ...

Oncological Outcomes in Bacillus Calmette-Guérin–naïve ...

Despite the efficacy of BCG therapy, 50–70% of HR-NMIBC cases recur within 5 yr, and 20–40% progress to muscle-invasive bladder cancer following BCG ...

Bacillus Calmette-Guérin (BCG) treatment patterns and ...

Details on maintenance duration were reported in 11 studies; among them, 27.9% of patients (1,154/4,142) completed ≥1 year of maintenance.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15947584/

Bacillus calmette-guerin versus chemotherapy for ... - PubMed

Conclusions: Intravesical BCG significantly reduces the risk of short and long-term treatment failure compared with intravesical chemotherapy. Therefore, it is ...

BCG Treatment for Bladder Cancer: Long-Term Side ...

However, even with BCG treatment, bladder cancer will come back in about 40 percent of people. The effectiveness of BCG can vary depending on ...

Safety profiles of intravesical Bacillus Calmette-Guerin in ...

Intravesical BCG exhibited lower immune-related AEs (irAEs) risk than anti-PD-1/PD-L1 treatment, but antibiotics increased the risk.

Clinical Outcomes in Bacillus Calmette-Guérin–Exposed Non ...

Among patients with recurrence, those who were BCG exposed accounted for 83.0% (366 of 441) of disease progression and 87.8% (337 of 384) of ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37852817/

Bacillus Calmette-Guerin (BCG) therapy is safe and ... - PubMed

Bacillus Calmette-Guerin (BCG) therapy is safe and effective in non-muscle invasive bladder cancer (NMIBC) patients with immunomodulating ...

BCG Treatment: What It Is, Procedure & Side Effects

Unlike oral or injectable drugs, BCG treatment targets cancer cells inside of your bladder without having a negative impact on the rest of your ...