Actively Recruiting
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of 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
183 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
This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.
CONDITIONS
Official 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 within 3 months
- Bacillus Calmette Guerin (BCG)-unresponsive or intolerant non-muscle invasive bladder cancer
- Refusal or intolerance of recommended radical cystectomy
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Life expectancy greater than 24 months
- No concurrent radiotherapy, chemotherapy, or immunotherapy for bladder cancer
- No BCG or other intravesical treatment within 4 weeks prior to study
- No scheduled radiotherapy, chemotherapy, immunotherapy, or surgery before response evaluation
- Recovery from prior treatment side effects
- Absolute neutrophil count at least 1,500/µL
- Platelets at least 100,000/µL (transfusion allowed)
- Hemoglobin at least 8 g/dL (transfusion allowed)
- Glomerular filtration rate of 30 mL/min or higher
- Total bilirubin less than or equal to 2.0 times institutional upper limit (3 times for Gilbert's syndrome)
- AST, ALT, ALP less than or equal to 3.0 times institutional upper limit
- Adequate lung function without severe dysfunction
- Use of adequate contraception or surgical sterilization for participants of childbearing potential
- Ability to understand and sign informed consent
- Ability and willingness to follow study schedule and requirements
You will not qualify if you...
- Cancer in the upper urinary tract
- Use of other investigational agents
- Evidence of regional or distant metastasis
- Severe heart conditions such as NYHA class III or IV heart failure or recent myocardial infarction
- Intractable bleeding disorders
- Use of certain anticoagulant medications (except low-dose aspirin 81 mg daily)
- Uncontrollable central nervous system disease
- Active systemic infection requiring intravenous antibiotics
- Pregnancy or breastfeeding
- Other malignancies diagnosed within 3 years except certain low-risk skin or cervical cancers and treated prostate cancer with low PSA
- Inability to understand or provide informed consent
- Any condition that might endanger safety or compliance during the trial
AI-Screening
AI-Powered Screening
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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
CONTACT
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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