Home-Based BCG for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma. Bacillus Calmette Guerin (BCG) is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. For patients with bladder cancer it is used in a solution and placed directly into the bladder to stimulate the immune system to attack the cancer cells. Bladder cancer patients often face frequent clinic visits for BCG treatment, creating time, cost, and require help from caregivers or family members. BCG treatment may be able to be given at home which would improve access and quality of care without compromising treatment effectiveness for patients with non-muscle invasive bladder carcinoma.
Who Is on the Research Team?
Cheryl T Lee, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for people diagnosed with non-muscle invasive bladder cancer who are eligible to receive BCG treatment. Participants should be able to safely have treatments at home and follow study instructions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- BCG Solution
Trial Overview
The study is testing if giving BCG bladder cancer treatment at home, instead of in a clinic, is practical and safe. Patients will get care from health professionals during home visits and complete surveys about their experience.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
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