Actively Recruiting
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Led by Mayo Clinic · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
88 weeks
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
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.
CONDITIONS
Official Title
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) receiving induction or maintenance intravesical therapy with gemcitabine, sequential gemcitabine/docetaxel, bacillus Calmette-Guerin, or mitomycin C
- Able to be successfully catheterized and tolerate first dose of intravesical therapy in outpatient clinic (Phase Ib only)
- Living within area serviced by supplier network
- Residence has Wi-Fi or cellular data connection for telehealth visits
- Age 18 years or older at registration
- Signed informed consent form
- Willing and able to follow study protocol
- Ability to complete questionnaires alone or with help
- Willing to follow birth control requirements if of reproductive potential
You will not qualify if you...
- Receiving investigational or standard cancer treatment for non-muscle invasive bladder cancer not part of eligible regimens
- Actively receiving other cancer treatments except hormone therapy for breast/prostate cancer or treatment for non-invasive skin cancer
- Needing 24/7 help with daily living activities
- Currently hospitalized (except Advanced Care at Home program)
- Severe illnesses or diseases that interfere with safety or assessment
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, recent heart attack (within 6 months), wound healing issues, or psychiatric/social problems limiting compliance
- Expecting major surgery during study treatment
- Known allergy or intolerance to study drugs
- Pregnant or breastfeeding
- Allergic to polysorbate 80 or paclitaxel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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