What this study is
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.
What's being tested
- BCG Solution
Intervention · BIOLOGICAL
- Cystoscopy
Intervention · PROCEDURE
Undergo cystoscopy
- Docetaxel
Intervention · DRUG
- Gemcitabine
Intervention · DRUG
- Home Health Encounter
Intervention · OTHER
Receive access to CCBW home health visits
- Mitomycin
Intervention · DRUG
- Questionnaire Administration
Intervention · OTHER
Ancillary studies
All of BCG Solution, Docetaxel, Gemcitabine, Mitomycin
Given intravesically
Study details
- 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
- Sponsor
- Mayo Clinic
- Conditions
- Non-Muscle Invasive Bladder Carcinoma · Stage 0a Bladder Cancer AJCC v8 · Stage I Bladder Cancer AJCC v8 · Stage 0is Bladder Cancer AJCC v8
- Enrolling
- 40 people
- Starts
- 2025-04-21
- Est. completion
- 2028-12-31
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedPhase II
You may qualify if
- PHASE IB AND PHASE II: 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
- Residing within the area serviced by supplier network
- Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits
- Age ≥ 18 years at time of registration
- Signed informed consent form by patient
- Willing and able to comply with the study protocol in the investigator's judgment
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to follow birth control requirements for females and males of reproductive potential
You can't join if
- Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens
- Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
- Requiring 24/7 assistance with activities of daily living (ADLs)
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to:; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Myocardial infarction ≤ 6 months; Wound healing disorder; Psychiatric illness/social situations that would limit compliance with study requirements
- Anticipation of the need for major surgery during the course of study treatment
- Known allergy or previous intolerance to drug regimens
- Pregnancy or breastfeeding
- Hypersensitivity or allergy to polysorbate 80 or paclitaxel
Phase IB
You may qualify if
- PHASE IB AND PHASE II: 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 IB ONLY: Able to be successfully catheterized and able to tolerate first dost of intravesical therapy in the outpatient clinic
- Residing within the area serviced by supplier network
- Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits
- Age ≥ 18 years at time of registration
- Signed informed consent form by patient
- Willing and able to comply with the study protocol in the investigator's judgment
- Ability to complete questionnaire(s) by themselves or with assistance
- Willingness to follow birth control requirements for females and males of reproductive potential
You can't join if
- Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens
- Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
- Requiring 24/7 assistance with activities of daily living (ADLs)
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to:; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Myocardial infarction ≤ 6 months; Wound healing disorder; Psychiatric illness/social situations that would limit compliance with study requirements
- Anticipation of the need for major surgery during the course of study treatment
- Known allergy or previous intolerance to drug regimens
- Pregnancy or breastfeeding
- Hypersensitivity or allergy to polysorbate 80 or paclitaxel
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Florida
Jacksonville, Florida, United States
- Clinical Trials Referral Office · Contact855-776-0015mayocliniccancerstudies@mayo.edu
- Timothy D. Lyon, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID MC240502
Principal investigator
Timothy D. Lyon, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.