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
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
Treatments tested in this trial
- PLZ4-coated paclitaxel-loaded micelles (PPM)
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
VA Office of Research and Development
Lead sponsor
University of California, Davis
Collaborator
Source ClinicalTrials.gov