At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed NMIBC (Ta, CIS, or T1) via TURBT within 3 months
- ✓BCG-unresponsive disease: persistent/recurrent CIS or high-grade Ta/T1 within 12 months of adequate BCG, or T1 high-grade at first evaluation after induction BCG
- ✓BCG intolerance or refusal of radical cystectomy
- ✓Age ≥18 years at consent
- ✕Cancer at upper urinary tract
- ✕Regional or distant metastasis
- ✕Concurrent investigational agents
- ✕NYHA class III or IV heart failure, uncontrollable arrhythmias, history of ventricular arrhythmia, or severe cardiac dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer
In Brief
A Phase 1 clinical trial evaluating PLZ4-coated paclitaxel loaded micelles (PPM) for Recurrent Non-Muscle Invasive Bladder Carcinoma and 3 related conditions. Currently recruiting, targeting 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given PLZ4-coated paclitaxel loaded micelles intravesically