In-home chemotherapy for bladder cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for recurrent or refractory non-muscle invasive bladder cancer using targeted nanoparticles

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• Adding gemcitabine to BCG for people with recurrent non‑muscle invasive bladder cancer.

  This phase III test tries whether giving intravesical gemcitabine alongside BCG helps people whose non‑muscle invasive bladder cancer has come back after prior BCG.

  Recruiting at 60 sites Phase 3 Alliance for Clinical Trials in Oncology · Birmingham, Alabama and 59 other locations · NCT07000084

• Cruciferous vegetable eating program to reduce recurrence and progression in early-stage bladder cancer

  This trial will test whether a behavioral program that increases cruciferous vegetable intake (like broccoli, cabbage, kale) and a maintenance component can lower recurrence or progression in adults with early-stage non-muscle invasive bladder cancer.

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• Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)

  This study tests whether UGN-501 can be safely given into the bladder to treat adults with recurrent non-muscle invasive bladder cancer.

  Recruiting at 6 sites Phase 1 UroGen Pharma Ltd. · Queen Creek, Arizona and 14 other locations · NCT07725796

• TARA-002 vs chemotherapy for high-grade non-muscle invasive bladder cancer in adults not previously treated with BCG

  A phase 3 study tests whether TARA-002 can help adults with high-grade non-muscle invasive bladder cancer who haven’t had BCG, comparing it to standard intravesical chemotherapy.

  Recruiting at 11 sites Phase 3 Protara Therapeutics · Queen Creek, Arizona and 10 other locations · NCT07480356

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.