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Nanoparticle Therapy

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

Phase 1
Recruiting
Research Sponsored by Mamta Parikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG
Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study medication to first documentation of objective tumor progression, disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to disease progression, assessed at 12 months
Awards & highlights

Study Summary

This trial tests a new bladder cancer treatment, PPM, to see if it is safe, effective, and tolerable. PPM is a drug-loaded nanoparticle that targets and kills tumor cells.

Who is the study for?
This trial is for people with non-muscle invasive bladder cancer that has either returned after getting better or hasn't responded to other treatments. Participants should meet specific health criteria not detailed here.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new treatment called PPM, which targets tumor cells in the bladder using nanoparticles containing paclitaxel, a drug known to inhibit tumor growth.See study design
What are the potential side effects?
Possible side effects may include those commonly associated with chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bladder cancer does not respond to BCG treatment or I cannot tolerate BCG.
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I am able to care for myself and perform daily activities.
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My kidney function, measured by GFR, is at least 30 mL/min.
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My lungs work well enough for daily activities without severe problems.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study medication to first documentation of objective tumor progression, disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to disease progression, assessed at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study medication to first documentation of objective tumor progression, disease recurrence, bladder resection or irradiation, other anti-bladder cancer therapy, or to death due to disease progression, assessed at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment related adverse events
Secondary outcome measures
Event-free survival
Tumor response

Trial Design

1Treatment groups
Experimental Treatment
Group I: PLZ4-coated paclitaxel loaded micelles (PPM)Experimental Treatment1 Intervention
Patients receive PPM intravesically over 1 hour QW for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or PET, and cystoscopy with biopsy at screening and follow up and undergo collection of blood samples throughout the trial.

Find a Location

Who is running the clinical trial?

Mamta ParikhLead Sponsor
6 Previous Clinical Trials
198 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,429 Total Patients Enrolled

Frequently Asked Questions

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

Is this research endeavor presently seeking participants?

"According to the clinicaltrials.gov database, this medical trial is actively seeking participants. This investigation was first announced on November 22nd 2023 and underwent recent revision as of December 7th that same year."

Answered by AI

To what extent can researchers recruit participants for this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is seeking participants and was first uploaded on November 22nd 2023 before being updated most recently in December 7th 2023; 12 individuals need to be recruited from a single location."

Answered by AI

What risks have been associated with PLZ4-coated paclitaxel loaded micelles (PPM) treatment?

"With limited data supporting efficacy and safety, our team at Power judged the security of PLZ4-coated paclitaxel loaded micelles (PPM) to be a 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Mamta Parikh 2023. "PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173349.
~8 spots leftby Dec 2025
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