In-home Chemotherapy for Bladder Cancer: INVITE Trial

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06704191

Provider View

This clinical trial is exploring whether giving chemotherapy directly into the bladder at home is as safe and effective as receiving it in a clinic for patients with non-muscle invasive bladder cancer. The study aims to see if this approach is more convenient and preferable for patients.

Patient Parameters

Program Overview

This study is testing if chemotherapy drugs, like BCG, gemcitabine, docetaxel, and mitomycin C, can be safely and effectively administered at home for patients with non-muscle invasive bladder cancer. These drugs work by stopping cancer cells from growing and spreading. Normally, this treatment is given in a clinic, which can be disruptive to patients' lives. By offering the treatment at home, the study hopes to make it more convenient and less disruptive. The trial will compare the safety and patient satisfaction of at-home treatment versus in-clinic treatment.

Description

The main goals of this study are to ensure that giving chemotherapy directly into the bladder at home is safe and feasible. The study will also look at how satisfied patients are with receiving treatment at home.

Other goals include:

  • Understanding how patients feel about their health and quality of life during the study.
  • Tracking any side effects reported by patients.
  • Counting the number of days patients can stay at home during the study.
  • Checking how often patients need unplanned visits to their urology care team.
  • Measuring how long patients stay free of cancer after the treatment period.

Treatment Plan:

Induction Phase (Phase Ib and Phase II):

  • Patients will receive one of the following treatments in the clinic: BCG, gemcitabine, gemcitabine followed by docetaxel, or mitomycin C. This will be done once a week at home for up to 5 weeks, as long as the cancer does not progress and side effects are manageable.

Maintenance Phase (Phase II only):

  • Patients will continue receiving treatment at home with BCG, gemcitabine, gemcitabine followed by docetaxel, or mitomycin C, according to a set schedule, as long as the cancer does not progress and side effects are manageable.

Patients will also have regular check-ups, including a cystoscopy at the end of the study, and access to home health visits throughout the study. After finishing the treatment, patients will be followed up at 12 weeks and up to 1 year after starting the study.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with non-muscle invasive bladder cancer (stage Ta, Tis, or T1) currently receiving or eligible for specific intravesical treatments like gemcitabine, gemcitabine/docetaxel, BCG, or mitomycin C.
  • Able to have a catheter placed and tolerate the first dose of treatment in a clinic.
  • Live within the service area of the study's supplier network.
  • Have access to Wi-Fi or cellular data for virtual health visits.
  • Willing to sign a consent form and follow the study protocol.
  • Able to complete questionnaires with or without help.

Exclusion Criteria

  • Receiving other treatments for bladder cancer not part of the study.
  • Currently receiving other cancer treatments, except for certain hormone therapies or non-invasive skin cancer treatments.
  • Need 24/7 assistance with daily activities.
  • Currently hospitalized, unless part of a specific home care program.
  • Have other serious health conditions that could interfere with the study.
  • Have uncontrolled illnesses like infections, heart problems, or psychiatric issues.
  • Expect to need major surgery during the study.
  • Known allergies or past intolerance to the study drugs.
  • Pregnant or breastfeeding.

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