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Anti-metabolites

Intravesical PPM Therapy for Bladder Cancer

Phase 1
Recruiting
Led By Chong-Xian Pan, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refusal or intolerance of a radical cystectomy recommended by the treating urologist as the standard next therapy per urologic guidelines
BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 hours after administration
Awards & highlights

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

Who is the study for?
This trial is for adults with bladder cancer that hasn't spread into the muscle and didn't respond to BCG treatment. Participants need good lung function, can't have severe heart issues or other serious illnesses, must not be pregnant or nursing, and should agree to use birth control. They should also have a life expectancy of more than 24 months.Check my eligibility
What is being tested?
The trial tests PLZ4-coated paclitaxel-loaded micelles (PPM), designed to target bladder cancer cells specifically. PPM will be placed directly into the bladder in patients who haven’t responded well to prior treatments. The study aims to find the right dose for future trials and check its safety and early effectiveness.See study design
What are the potential side effects?
Possible side effects may include typical chemotherapy-related issues like irritation at the instillation site within the bladder, allergic reactions, fatigue, nausea, low blood cell counts increasing infection risk, bleeding complications or potential harm to liver or kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot or will not undergo major bladder surgery as advised.
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My bladder cancer has not responded to BCG treatment or I cannot tolerate BCG.
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I cannot or will not undergo major bladder surgery as advised.
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I am 18 years old or older.
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I have completed the recommended BCG treatment.
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I am not currently undergoing, nor scheduled for, any cancer treatments.
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My lungs work well and I don't have serious breathing problems.
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My bladder cancer was confirmed by a biopsy within the last 3 months and a recent cystoscopy showed no deep muscle invasion.
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I have recovered from any major side effects of previous treatments.
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I can care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 hours after administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 hours after administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
adverse events
Secondary outcome measures
complete response rate
Other outcome measures
blood paclitaxel concentration

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I dose-escalation and expansion cohortExperimental Treatment1 Intervention
There are three doses at the dose escalation stage: Dose level I: paclitaxel (PTX) 25 mg or 0.5 mg/ml; Dose Level II: PTX 50 mg or 1.0 mg/ml; Dose Level III: PTX 75 mg or 1.5 mg/ml. At the expansion cohort, up to 12 patients will be recruited and treated with PPM at the PTX dose of 50 mg or 1.0 mg/ml to determine the efficacy.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,400 Total Patients Enrolled
University of California, DavisOTHER
911 Previous Clinical Trials
4,709,554 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

Media Library

PLZ4-coated paclitaxel-loaded micelles (PPM) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05519241 — Phase 1
Bladder Cancer Research Study Groups: Phase I dose-escalation and expansion cohort
Bladder Cancer Clinical Trial 2023: PLZ4-coated paclitaxel-loaded micelles (PPM) Highlights & Side Effects. Trial Name: NCT05519241 — Phase 1
PLZ4-coated paclitaxel-loaded micelles (PPM) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519241 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper capacity of enrollees for this investigation?

"Affirmative. According to clinicaltrials.gov, the trial that began on October 10th 2022 is currently enrolling patients and has 29 vacancies at a single site. The details have been recently updated as of October 13th 2022."

Answered by AI

Are physicians currently seeking participants for this investigation?

"Clinicaltrials.gov has reported that the enrollment process for this clinical trial is ongoing. It was first posted on October 10th 2022 and recently revised on 13th of the same month."

Answered by AI

Has the Food and Drug Administration accepted PLZ4-coated paclitaxel-loaded micelles (PPM) for commercial use?

"PPM has only been tested in limited clinical settings and hence, our team at Power assessed its safety as a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Phase I Intravesical PPM Therapy for NMIBC
2022. "A Phase I Intravesical PPM Therapy for NMIBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05519241.
~18 spots leftby Aug 2026
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