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

Stage 0a Bladder Cancer AJCC v8 Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. Evaluate the safety and tolerability of PPM administered through intravesical instillation.

SECONDARY OBJECTIVES:

I. Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy.

II. Assess event-free survival rate at 12 months.

OUTLINE:

Patients receive PPM intravesically over 1 hour once a week (QW) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET), and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 3 weeks, 6 weeks, and then every 3 months per standard of care for 2 years. ;

Related Conditions & MeSH terms

• Recurrence
• Stage 0a Bladder Cancer AJCC v8
• Stage 0is Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8
• Urinary Bladder Neoplasms

• NCT number: NCT06173349
• Study type: Interventional
• Source: University of California, Davis
• Status: Recruiting
• Phase: Phase 1
• Start date: November 22, 2023
• Completion date: June 2026