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In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Sponsor: Mayo Clinic
Summary
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.
Official title: MC240502: Cancer CARE (Connected Access and Remote Expertise) Beyond Walls In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-04-21
Completion Date
2026-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
BCG Solution
Given intravesically
Cystoscopy
Undergo cystoscopy
Docetaxel
Given intravesically
Gemcitabine
Given intravesically
Home Health Encounter
Receive access to CCBW home health visits
Mitomycin
Given intravesically
Questionnaire Administration
Ancillary studies
Locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, United States