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RECRUITING
NCT06704191
PHASE1/PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

BCG Solution

Given intravesically

PROCEDURE

Cystoscopy

Undergo cystoscopy

DRUG

Docetaxel

Given intravesically

DRUG

Gemcitabine

Given intravesically

OTHER

Home Health Encounter

Receive access to CCBW home health visits

DRUG

Mitomycin

Given intravesically

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States