Actively Recruiting
A Phase I Trial of Cancer-targeting Micelles for Non-myoinvasive Bladder Cancer
Led by VA Office of Research and Development · Updated on 2025-09-02
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of California, Davis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called PLZ4-coated paclitaxel-loaded nanoscale micelles (PPM) for treating non-muscle-invasive bladder cancer (NMIBC) that has not responded to previous BCG therapy. This Phase I trial aims to find the recommended dose of PPM for future studies, assess its side effects, and gather early information about its potential effectiveness. The study involves up to 29 patients with recurrent or resistant NMIBC after standard BCG treatment. PPM is a tiny particle containing the chemotherapy drug paclitaxel, designed to target bladder cancer cells specifically. In this trial, PPM will be administered directly into the bladder once a week for six weeks through a procedure called intravesical instillation. The trial includes a dose escalation stage with three dose levels of paclitaxel (25 mg, 50 mg, and 75 mg), followed by an expansion phase where up to 12 patients receive the 50 mg dose to evaluate effectiveness. Participants will undergo regular assessments including urine cytology and cystoscopy to monitor cancer response. Side effects will be tracked using a standard toxicity scale for up to six weeks after the last dose. Blood tests and molecular studies will be performed to check for systemic absorption and other effects. The total participation includes weekly treatments for six weeks with follow-up evaluations to monitor safety and preliminary outcomes.
CONDITIONS
Brief Title
A Phase I Intravesical PPM Therapy for NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer, confirmed by biopsy within 3 months and cystoscopy showing no muscle invasion within 4 weeks
- BCG-unresponsive non-muscle-invasive bladder cancer or intolerance to BCG treatment
- Refusal or intolerance of recommended radical cystectomy
- Age 18 years or older
- ECOG performance status 0, 1, or 2 or Karnofsky performance status 50 or higher
- Life expectancy greater than 24 months
- No concurrent radiotherapy, chemotherapy, or immunotherapy
- No planned radiotherapy, chemotherapy, immunotherapy, or surgery before response evaluation
- Recovery from prior treatment side effects that might interfere with study treatment
- Adequate lab values within 14 days before enrollment: ANC ≥1500/uL, platelets ≥100,000/uL, hemoglobin ≥8 g/dL, GFR ≥50 mL/min/1.73m2, total bilirubin <2.0 x ULN (or <3 x ULN for Gilbert's syndrome), AST/ALT/ALP <3.0 x ULN
- Adequate lung function without severe pulmonary dysfunction
- Negative pregnancy test for females of childbearing potential
- Use of medically accepted birth control methods for females of childbearing potential and barrier methods for males during study and 3 months after
- Signed informed consent and agreement to comply with protocol procedures and follow-up
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 including NYHA Class III or IV heart failure, uncontrollable arrhythmias, recent myocardial infarction, or severe cardiac dysfunction
- Symptomatic congestive heart failure or unstable angina within 6 months
- Intractable bleeding disorders
- Use of anticoagulant medications other than low-dose aspirin
- Uncontrollable central nervous system disease
- Active systemic infection requiring IV antibiotics
- Pregnant or nursing women
- Psychiatric or social conditions limiting compliance
- Other illnesses deemed by investigators to exclude participation
- Any other malignancy diagnosed within 3 years except low-risk skin or cervical cancers or localized prostate cancer with PSA <0.2 ng/ml
- Inability or unwillingness to comply with study protocol
- Impaired decision-making capacity
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.
1 visit (in-person)
Duration - 6 weeks
Participants receive weekly intravesical instillations of PLZ4-coated paclitaxel-loaded micelles (PPM) for bladder cancer.
6 weekly visits (in-person)
Duration - Up to 6 weeks after the last dose
Participants are monitored for adverse events and preliminary efficacy after completing treatment.
1 to 2 visits (in-person) depending on assessments
Trial Site Locations
Total: 1 location
1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
Research Team
C
Chong-Xian Pan, MD PhD
L
Lori Lerner, MD
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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