PLZ4-coated paclitaxel-loaded micelles (PPM) for Non-muscle Invasive Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-muscle Invasive Bladder CancerPLZ4-coated paclitaxel-loaded micelles (PPM) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, PPM, for bladder cancer. 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

Eligible Conditions
  • Non-muscle Invasive Bladder Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: within 6 hours after administration

Week 6
complete response rate
Month 3
adverse events
Hour 6
blood paclitaxel concentration

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Phase I dose-escalation and expansion cohort
1 of 1

Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: PLZ4-coated paclitaxel-loaded micelles (PPM) · No Placebo Group · Phase 1

Phase I dose-escalation and expansion cohort
Drug
Experimental Group · 1 Intervention: PLZ4-coated paclitaxel-loaded micelles (PPM) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 6 hours after administration

Who is running the clinical trial?

University of California, DavisOTHER
844 Previous Clinical Trials
5,014,322 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,742,190 Total Patients Enrolled
Chong-Xian Pan, MD PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
29 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must meet all of the following criteria to be eligible for study entry.
Patients are eligible if the biopsy was done within 3 months of enrollment and a cystoscopy demonstrates no gross disease invasion into muscularis propria within 4 weeks of enrollment.