Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05519241

A Phase I Intravesical PPM Therapy for NMIBC

Led by VA Office of Research and Development · Updated on 2025-09-02

29

Participants Needed

1

Research Sites

203 weeks

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

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug paclitaxel. PLZ4 is a molecule that can possibly guide PPM to specifically target and deliver paclitaxel into and kill bladder cancer cells. In this trial, PPM will be instilled into the bladder cavity to treat bladder cancer that does not invade into the muscle layer of the bladder and that has failed the treatment of another drug BCG. Up to 29 patients will be enrolled into the trial. The main goal of this trial is to determine the dose of PPM for future clinical trials, assess the toxicity and obtain preliminary data regarding its effectiveness.

CONDITIONS

Official Title

A Phase I Intravesical PPM Therapy for NMIBC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer, biopsy within 3 months and cystoscopy showing no muscle invasion within 4 weeks
  • BCG-unresponsive or intolerant non-muscle-invasive bladder cancer (NMIBC) as defined by specific recurrence or persistence criteria after adequate 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 per investigator judgment
  • Laboratory values within defined limits including neutrophils, platelets, hemoglobin, kidney and liver function within 14 days prior to enrollment
  • Adequate pulmonary function without severe dysfunction
  • Negative pregnancy test for females of childbearing potential
  • Use of medically accepted birth control methods during study and for 3 months after or surgical sterilization
  • Signed informed consent and agreement to comply with protocol procedures and follow-up
Not Eligible

You will not qualify if you...

  • Presence of cancer in the upper urinary tract
  • Use of other investigational agents concurrently
  • Evidence of regional or distant metastasis
  • Severe cardiac conditions such as NYHA Class III or IV heart failure, uncontrolled arrhythmias, 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 nursing
  • Psychiatric or social conditions limiting study compliance
  • Other illnesses deemed exclusionary by investigator
  • Other malignancies diagnosed within 3 years except low-risk skin or cervical cancers or treated localized prostate cancer
  • Inability or unwillingness to comply with the study protocol
  • Impaired decision-making capacity

AI-Screening

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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

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Research Team

C

Chong-Xian Pan, MD PhD

CONTACT

L

Lori Lerner, MD

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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