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
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PHASE IB ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens * Gemcitabine * Sequential gemcitabine/docetaxel * Bacillus Calmette-Guerin * Mitomycin C * PHASE II ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis or T1) who are receiving maintenance therapy with an eligible regimen * PHASE IB ONLY: Able to be successfully cathet…
Interventions
- BiologicalBCG Solution
Given intravesically
- ProcedureCystoscopy
Undergo cystoscopy
- DrugDocetaxel
Given intravesically
- DrugGemcitabine
Given intravesically
- OtherHome Health Encounter
Receive access to CCBW home health visits
- DrugMitomycin
Given intravesically
- OtherQuestionnaire Administration
Ancillary studies
Location
- Mayo Clinic in FloridaJacksonville, Florida