Ohio State University Comprehensive Cancer Center
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.
PRIMARY OBJECTIVES: I. To evaluate the feasibility of home-based delivery of intravesical BCG therapy as measured by successful administration of BCG therapy in at least four of five in-home induction doses. II. To evaluate the correct administration of intravesical BCG. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients achieving an adequate therapy regimen, defined as at least five of six induction instillations (including the first in-clinic dose) plus at least two of three maintenance instillations. II. To evaluate the safety of home-based intravesical BCG, measured by th…
Inclusion Criteria: * At least 18 years of age at the time of enrollment * Able and willing to provide signed informed consent, confirming voluntary participation and understanding of study-related information and procedures * Determined by the investigator to be capable and willing to comply fully with the study protocol, including the independent or assisted completion of required questionnaires * Pathological confirmation of NMIBC, with transurethral resection of bladder tumor (TURBT) completed within the past 6 weeks. In cases of cT1, the 6-week window may apply from the date of a second…
Given via installation in the bladder
Receive BCG in a hospital-based clinical setting
Undergo cystoscopy
Receive BCG installation at home by trained home health nurses
Ancillary studies
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