RecruitingPhase 1NCT06173349

PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer


Sponsor

University of California, Davis

Enrollment

12 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug treatment delivered directly into the bladder for people with non-muscle invasive bladder cancer (cancer that hasn't grown deep into the bladder wall) that has stopped responding to BCG therapy — the standard first-line treatment. **You may be eligible if...** - You have been diagnosed with non-muscle invasive bladder cancer confirmed by biopsy within the past 3 months - Your cancer has not responded to BCG treatment (a common immune-based bladder therapy), or you cannot tolerate BCG - Your cancer returned or persisted within 12 months of completing adequate BCG treatment - You are not a candidate for or have declined bladder removal surgery **You may NOT be eligible if...** - Your cancer has grown into the muscle layer of the bladder or spread beyond it - You have not yet tried BCG treatment (unless you have an intolerance to it) - You have active urinary tract infections or other conditions affecting the bladder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPLZ4-coated paclitaxel loaded micelles (PPM)

Given PLZ4-coated paclitaxel loaded micelles intravesically


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

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NCT06173349


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