RecruitingPhase 1Phase 2NCT06704191

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

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

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Muscle Invasive Bladder Carcinoma Stage 0a Bladder Cancer AJCC v8 Stage 0is Bladder Cancer AJCC v8 Stage I Bladder Cancer AJCC v8

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether bladder cancer patients can safely receive their regular bladder chemotherapy treatments at home (intravesical therapy, where medication is placed directly into the bladder through a catheter), instead of having to travel to a clinic each time. **You may be eligible if...** - You are 18 or older - You have confirmed non-muscle invasive bladder cancer (cancer that hasn't spread into the bladder muscle) at stages Ta, Tis, or T1 - You are currently receiving or will begin a standard bladder treatment (gemcitabine, BCG, mitomycin C, or gemcitabine/docetaxel) - You live within the area served by the study's home care supplier network - You have Wi-Fi or cell data at home for virtual check-in visits **You may NOT be eligible if...** - You are receiving other cancer treatments at the same time (except hormone therapy for breast or prostate cancer) - You are receiving an experimental treatment for bladder cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.