In-home chemotherapy for bladder cancer treatment
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
PHASE1; PHASE2 · Mayo Clinic · NCT06704191
This study tests whether giving chemotherapy for bladder cancer at home is safe and more convenient for patients compared to getting it in a clinic.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06704191 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and acceptability of administering intravesical chemotherapy for non-muscle invasive bladder cancer in a patient's home compared to traditional in-clinic administration. Patients will receive various chemotherapy agents, including BCG, gemcitabine, docetaxel, and mitomycin C, through a catheter. The study aims to assess patient satisfaction, quality of life, and the feasibility of home delivery of treatment. By reducing the need for frequent clinic visits, the trial seeks to improve the overall experience for patients and caregivers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed non-muscle invasive bladder cancer who can tolerate intravesical therapy.
Not a fit: Patients with muscle-invasive bladder cancer or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the convenience and comfort of chemotherapy for bladder cancer patients.
How similar studies have performed: Other studies have shown promise in home-based cancer therapies, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PHASE IB ONLY: 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 * 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 Exclusion Criteria: * 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Timothy D. Lyon, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8