RecruitingPhase 1NCT05519241

A Phase I Intravesical PPM Therapy for NMIBC

A Phase I Trial of Cancer-targeting Micelles for Non-myoinvasive Bladder Cancer


Sponsor

VA Office of Research and Development

Enrollment

29 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment delivered directly into the bladder (called intravesical PPM therapy — a combination of paclitaxel, preceded by mitomycin) for patients with non-muscle-invasive bladder cancer that has not responded to standard BCG therapy. **You may be eligible if...** - You have been diagnosed with bladder cancer in situ or early-stage bladder cancer (not invading muscle) - Your cancer has not responded to adequate BCG treatment, or you cannot tolerate BCG - Your cancer has come back within 12 months of completing BCG therapy, or you had persistent disease - You are willing to undergo the bladder treatment and related procedures **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle wall (muscle-invasive disease) - You have had a previous serious adverse reaction to the study drugs - You are not eligible based on other medical conditions assessed by the study team - You are pregnant or planning to become pregnant 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)

PPM will be administrated weekly for 6 times through intravesical instillation into the bladder cavity


Locations(1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

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NCT05519241


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