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

Official title

MC240502: Cancer CARE (Connected Access and Remote Expertise) Beyond Walls In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes

Overview

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.

Interventions

• Biological BCG Solution
  Given intravesically
• Procedure Cystoscopy
  Undergo cystoscopy
• Drug Docetaxel
  Given intravesically
• Drug Gemcitabine
  Given intravesically
• Other Home Health Encounter
  Receive access to CCBW home health visits
• Drug Mitomycin
  Given intravesically
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• Incidence and severity of adverse events (AEs) [Time frame: 12 weeks]
• Feasibility of in-home intravesical therapy [Time frame: 12 weeks]

Secondary outcome measures (2)

• Patient-preferred treatment location [Time frame: Up to 1 year]
• Patient-reported likelihood to recommend at home therapy [Time frame: Up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT06704191 · MC240502 · UL1TR002377 · NCI-2024-09555 · 24-002176 · MC240502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗