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

NCT06704191 | Recruiting Phase 1

• 4 other identifiers: MC240502UL1TR002377NCI-2024-0955524-002176
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  The incidence, type, and severity of AEs experienced will be reported. The maximum grade for each type of AE will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  12 weeks

• Feasibility of in-home intravesical therapy

  Feasibility will be indicated by the proportion of patients who receive at least 4 of 5 planned doses of induction therapy in the home within 12 weeks of the first dose of intravesical therapy (received in the outpatient clinic).

  12 weeks

Secondary Outcomes (2)

• Patient-preferred treatment location

  Up to 1 year

• Patient-reported likelihood to recommend at home therapy

  Up to 1 year

Study Arms (1)

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

EXPERIMENTAL

INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin C intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo cystoscopy at end of study and receive access to CCBW home health visits throughout the study.

Biological: BCG Solution; Procedure: Cystoscopy; Drug: Docetaxel; Drug: Gemcitabine; Other: Home Health Encounter; Drug: Mitomycin; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Ancillary studies

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

BCG Solution BIOLOGICAL

Given intravesically

Also known as: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Cystoscopy PROCEDURE

Undergo cystoscopy

Also known as: CS

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Docetaxel DRUG

Given intravesically

Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Gemcitabine DRUG

Given intravesically

Also known as: dFdC, dFdCyd, Difluorodeoxycytidine

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Home Health Encounter OTHER

Receive access to CCBW home health visits

Also known as: HH, Home, Home Care Visit, Home Health

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Mitomycin DRUG

Given intravesically

Also known as: Ametycine, Jelmyto, MITO, Mito-C, Mito-Medac, Mitocin, Mitocin-C, Mitomycin C, Mitomycin pyelocalyceal, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706, Mitolem

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Interventions

Cystoscopy; Docetaxel; Gemcitabine; Home Care Services; House Calls; Mitomycin; Mitozytrex

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services; Professional Practice; Organization and Administration; Health Services Administration; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Timothy D. Lyon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)