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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06350734 -
Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
|
||
| Recruiting |
NCT06126796 -
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
|
||
| Recruiting |
NCT04164082 -
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
| Completed |
NCT00749892 -
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
|
Phase 2 | |
| Completed |
NCT04496219 -
Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04501913 -
Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
|
||
| Completed |
NCT04548193 -
Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship
|
Phase 1 | |
| Recruiting |
NCT05843448 -
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
|
Phase 1 |