A Phase I Intravesical PPM Therapy for NMIBC

ConditionNon-muscle-invasive Bladder Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorVA Office of Research and Development

About this trial

This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." 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 Bacillus Calmette-Guérin (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 the toxicity and obtain preliminary data regarding its effectiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed bladder carcinoma in situ (CIS) urothelial or urothelial carcinoma, with or without T1 cancer. 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.

Patient must have BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG. Treatment of pembrolizumab is not an inclusion or

Disqualifiers

Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy

Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy

T1 high-grade disease at the first evaluation following an induction BCG course

At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy

Trial design

Design model

Single group

Treatments tested in this trial

PLZ4-coated paclitaxel-loaded micelles (PPM)
Drug
PPM will be administrated weekly for 6 times through intravesical instillation into the bladder cavity

Treatment groups

29 Participants

are divided into 1 treatment group

Group A: Phase I dose-escalation and expansion cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

adverse events

Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used to determine any adverse events and assess the grade. All toxicity as well as Grade 3 or higher adverse events will be analyzed.

Time frame

up to 6 weeks after the last dose

Secondary outcomes

complete response rate

urine cytology, cystoscopy.

Time frame

6 weeks after finishing the last dose of PPM

Other outcomes

blood paclitaxel concentration

Blood will be drawn up to a few hours after the first dose of PPM at the expansion cohort to determine the systemic paclitaxel absorption.

Time frame

within 6 hours after administration

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

University of California, Davis

Collaborator

Source ClinicalTrials.gov

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