RECRUITING

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MC240502 In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes

Quick Facts

Study Start:2025-04-21
Study Completion:2026-06-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06704191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Gemcitabine
  3. * Sequential gemcitabine/docetaxel
  4. * Bacillus Calmette-Guerin
  5. * Mitomycin C
  6. * 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
  7. * PHASE IB ONLY: Able to be successfully catheterized and able to tolerate first dost of intravesical therapy in the outpatient clinic
  8. * Residing within the area serviced by supplier network
  9. * Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits
  10. * Age ≥ 18 years at time of registration
  11. * Signed informed consent form by patient
  12. * Willing and able to comply with the study protocol in the investigator's judgment
  13. * Ability to complete questionnaire(s) by themselves or with assistance
  1. * 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
  2. * Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)
  3. * Requiring 24/7 assistance with activities of daily living (ADLs)
  4. * Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
  5. * 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
  6. * Uncontrolled intercurrent illness including, but not limited to:
  7. * Ongoing or active infection
  8. * Symptomatic congestive heart failure
  9. * Unstable angina pectoris
  10. * Cardiac arrhythmia
  11. * Myocardial infarction ≤ 6 months
  12. * Wound healing disorder
  13. * Psychiatric illness/social situations that would limit compliance with study requirements
  14. * Anticipation of the need for major surgery during the course of study treatment
  15. * Known allergy or previous intolerance to drug regimens
  16. * Pregnancy or breastfeeding

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Timothy D. Lyon, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Timothy D. Lyon, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2026-06-06

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2026-06-06

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Muscle Invasive Bladder Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8