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

NCT ID: NCT06704191

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2026-06-06

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To characterize the safety of in-home delivery of intravesical therapy. II. To assess the feasibility of in-home delivery of intravesical therapy.

SECONDARY OBJECTIVE:

I. To evaluate patient satisfaction with in-home intravesical therapy.

OTHER OBJECTIVES:

I. To assess patient-reported function and global health status/quality of life.

II. To assess patient-reported adverse events. III. To assess home days during study period. IV. To assess patient satisfaction with in-home intravesical therapy. V. To assess unplanned interactions with urological care team. VI. To describe disease-free survival rates following intervention period.

OUTLINE:

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 (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 Cancer Care Beyond Walls (CCBW) home health visits throughout the study.

After completion of study treatment, patients are followed up at 12 weeks from registration and up to 1 year after registration.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (BCG, gemcitabine, docetaxel, mitomycin)

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.

Group Type: EXPERIMENTAL

BCG Solution

Intervention Type: BIOLOGICAL

Given intravesically

Cystoscopy

Intervention Type: PROCEDURE

Undergo cystoscopy

Docetaxel

Intervention Type: DRUG

Given intravesically

Gemcitabine

Intervention Type: DRUG

Given intravesically

Home Health Encounter

Intervention Type: OTHER

Receive access to CCBW home health visits

Mitomycin

Intervention Type: DRUG

Given intravesically

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

BCG Solution

Given intravesically

Intervention Type: BIOLOGICAL

Cystoscopy

Undergo cystoscopy

Intervention Type: PROCEDURE

Docetaxel

Given intravesically

Intervention Type: DRUG

Gemcitabine

Given intravesically

Intervention Type: DRUG

Home Health Encounter

Receive access to CCBW home health visits

Intervention Type: OTHER

Mitomycin

Given intravesically

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Bacillus Calmette Guerin Solution; Bacillus Calmette-Guerin Solution; TICE BCG Solution; CS; Docecad; RP 56976; RP-56976; RP56976; Taxotere; Taxotere Injection Concentrate; dFdC; dFdCyd; Difluorodeoxycytidine; HH; Home; Home Care Visit; Home Health; 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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy D. Lyon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

UL1TR002377

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-09555

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-002176

Identifier Type: OTHER

Identifier Source: secondary_id

MC240502

Identifier Type: OTHER

Identifier Source: secondary_id

MC240502

Identifier Type: -

Identifier Source: org_study_id