Actively Recruiting
Cancer CARE Beyond Walls In-home Intravesical Therapy (INVITE) Study Comparing Home and Clinic Chemotherapy Delivery for Bladder Cancer
Led by Mayo Clinic · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and acceptability of delivering intravesical chemotherapy at home versus traditional in-clinic administration for patients with non-muscle invasive bladder cancer. This phase Ib/II trial focuses on comparing how well patients tolerate treatments like bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, which target tumor cells to stop their growth or spread. The study aims to find out if home delivery can reduce the disruption caused by frequent clinic visits while maintaining treatment safety and patient satisfaction. Participants receive intravesical chemotherapy either in the clinic or at home. During the induction phase, patients are treated with one of the drugs—BCG, gemcitabine, sequential gemcitabine/docetaxel, or mitomycin C—administered directly into the bladder over 1 to 2 hours. Treatment is given once weekly at home for up to 5 weeks if there is no disease progression or unacceptable side effects. In the maintenance phase, only phase II patients continue with monthly or weekly home treatments for up to 3 months depending on the drug used. Patients also have cystoscopy at the end of the study and receive home health visits through the Cancer Care Beyond Walls program. Throughout the study, participants complete questionnaires on their health, quality of life, and any adverse effects they experience. Researchers monitor safety by tracking adverse events and assess how feasible home therapy is over 12 weeks. Additional outcomes include patient preference for treatment location and likelihood to recommend home therapy over up to one year. Follow-up visits occur 12 weeks after registration and continue for up to one year to observe disease status and treatment effects.
CONDITIONS
Brief Title
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with non-muscle invasive bladder cancer (stage Ta, Tis, or T1)
- Currently receiving or maintaining treatment with gemcitabine, sequential gemcitabine/docetaxel, BCG, or mitomycin C
- Able to be catheterized and tolerate intravesical therapy in outpatient clinic
- Reside within the supplier network service area
- Residence has Wi-Fi or cellular data for telehealth visits
- Signed informed consent
- Willing and able to comply with study protocol
- Able to complete questionnaires alone or with help
- Willing to follow birth control requirements if of reproductive potential
You will not qualify if you...
- Receiving other investigational or standard treatments not part of eligible regimens for non-muscle invasive bladder cancer
- Actively receiving other cancer treatments except hormone therapy for breast or prostate cancer or treatment for non-invasive skin cancer
- Require 24/7 assistance with activities of daily living
- Currently hospitalized (except Advanced Care at Home program)
- Severe concurrent illnesses or conditions that interfere with safety or study assessment
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, cardiac arrhythmias, recent myocardial infarction (within 6 months), wound healing disorders, psychiatric or social issues limiting compliance
- Anticipated need for major surgery during study
- Known allergy or intolerance to study drugs
- Pregnant or breastfeeding
- Allergy to polysorbate 80 or paclitaxel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants receive intravesical chemotherapy in the clinic and then weekly at home for up to 5 weeks if there is no disease progression or unacceptable toxicity.
Weekly visits at home
Duration - Up to 3 months
Participants in the Phase II cohort continue intravesical chemotherapy at home with varying schedules depending on the drug, in the absence of disease progression or unacceptable toxicity.
Weekly visits for 3 weeks and monthly visits for 3 months at home
Duration - Throughout the study
Participants undergo cystoscopy at the end of the study and receive ongoing home health visits throughout the study period.
Cystoscopy at end of study and ongoing home health visits
Duration - Up to 1 year
Participants are followed up for safety, feasibility, and patient-reported outcomes up to 1 year after registration.
Visits at 12 weeks and periodic follow-ups up to 1 year
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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