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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06704191
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCG Solution — BIOLOGICAL
    Given intravesically
  • Cystoscopy — PROCEDURE
    Undergo cystoscopy
  • Docetaxel — DRUG
    Given intravesically
  • Gemcitabine — DRUG
    Given intravesically
  • Home Health Encounter — OTHER
    Receive access to CCBW home health visits
  • Mitomycin — DRUG
    Given intravesically
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 21, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Timothy D. Lyon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic in Florida· Jacksonville, FL

Related Studies