This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06704191.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in FloridaStatus: Active
Contact: Timothy David Lyon
Phone: 904-953-2000
PRIMARY OBJECTIVES:
I. To characterize the safety of in-home delivery of intravesical therapy.
II. To assess the feasibility of in-home delivery of intravesical therapy.
SECONDARY OBJECTIVE:
I. To evaluate patient satisfaction with in-home intravesical therapy.
OTHER OBJECTIVES:
I. To assess patient-reported function and global health status/quality of life.
II. To assess patient-reported adverse events.
III. To assess home days during study period.
IV. To assess patient satisfaction with in-home intravesical therapy.
V. To assess unplanned interactions with urological care team.
VI. To describe disease-free survival rates following intervention period.
OUTLINE:
INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin (mitomycin C) intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity.
MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo cystoscopy at end of study and receive access to Cancer Care Beyond Walls (CCBW) home health visits throughout the study.
After completion of study treatment, patients are followed up at 12 weeks from registration and up to 1 year after registration.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorTimothy David Lyon
