Actively Recruiting
A Phase I Trial of PLZ4-Coated Paclitaxel-Loaded Micelles for Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Led by University of California, Davis · Updated on 2026-03-13
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of PLZ4-coated paclitaxel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has returned after improvement or has not responded to prior treatment. This phase I trial focuses on a nanoparticle designed to specifically target and deliver paclitaxel to bladder tumor cells. The study aims to understand how well this targeted treatment can work for patients with recurrent or refractory bladder cancer. Participants receive PPM through a bladder instillation over one hour once a week for six weeks, provided there is no disease progression or unacceptable side effects. Before and during the trial, patients undergo imaging tests like CT, MRI, or PET scans, along with cystoscopy and biopsy to monitor the bladder tumors. Blood samples are also collected throughout the study to assess health and treatment effects. After completing the treatment phase, patients are followed up at 3 weeks, 6 weeks, and then every 3 months for two years as part of standard care. Researchers evaluate tumor response six weeks after treatment ends and track event-free survival over 12 months, including monitoring for tumor progression, recurrence, or additional treatments. Safety is closely monitored from the first dose until 12 months after the last dose to understand any treatment-related side effects.
CONDITIONS
Brief Title
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-muscle invasive bladder cancer (Ta, CIS, or T1) diagnosed via transurethral resection within 3 months
- Bacillus Calmette Guerin (BCG)-unresponsive or intolerant to BCG treatment
- Refuse or intolerant of recommended radical cystectomy
- Age 18 years or older at consent
- ECOG performance status 0, 1, or 2
- Life expectancy greater than 24 months
- No concurrent radiotherapy, chemotherapy, or immunotherapy for bladder cancer
- No BCG or intravesical treatment within 4 weeks prior
- Adequate recovery from prior treatment side effects
- Absolute neutrophil count ≥ 1,500/µL
- Platelets ≥ 100,000/µL (transfusion allowed)
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- Glomerular filtration rate ≥ 30 mL/min
- Total bilirubin ≤ 2.0 × institutional upper limit (or <3 × ULN for Gilbert's syndrome)
- AST, ALT, ALP ≤ 3.0 × institutional upper limit
- Adequate lung function with no severe pulmonary dysfunction
- Use of adequate contraception for participants of childbearing potential during study and 3 months after
- Ability to understand and sign informed consent
- Willingness to follow study visit schedule and protocol requirements
You will not qualify if you...
- Presence of cancer in the upper urinary tract
- Use of other investigational agents
- Evidence of regional or distant metastasis
- Severe heart conditions including NYHA class III/IV heart failure or recent myocardial infarction
- Intractable bleeding disorders or use of certain blood-thinning medications except low-dose aspirin
- Uncontrollable central nervous system disease
- Active systemic infection requiring intravenous antibiotics
- Pregnancy or breastfeeding
- Any other malignancy diagnosed within 3 years except certain low-risk cancers
- Conditions preventing informed consent
- Any condition interfering with safety or compliance during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
/CT, MRI, or PET, and cystoscopy with biopsy at screening.
Duration - 6 weeks
Participants receive PLZ4-coated paclitaxel loaded micelles intravesically over 1 hour once a week for 6 weeks if there is no disease progression or unacceptable toxicity.
Weekly visits for 6 weeks (in-person)
Duration - 2 years
After completing treatment, participants are followed up at 3 weeks, 6 weeks, and then every 3 months per standard of care for 2 years to monitor safety and tumor response.
Follow-up visits at 3 weeks, 6 weeks, and every 3 months thereafter
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
O
Office of Clinical Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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