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PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

ConditionsRecurrent Non-Muscle Invasive Bladder CarcinomaStage 0a Bladder Cancer AJCC v8Stage 0is Bladder Cancer AJCC v8Stage I Bladder Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1), determined via transurethral resection of bladder tumor (TURBT) within 3 months of enrollment

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 12 months of completion of adequate BCG therapy

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

Disqualifiers

Existence of cancer at the upper urinary tract

Concurrent use of other investigational agents

Evidence of regional and/or distant metastasis

NYHA (New York Heart Association) class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction

Trial design

Design model

Single group

Treatments tested in this trial

  • PLZ4-coated paclitaxel loaded micelles (PPM)

    Drug

    Given PLZ4-coated paclitaxel loaded micelles intravesically

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: PLZ4-coated paclitaxel loaded micelles (PPM)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment related adverse events

Number of participants experiencing treatment-related AEs, classified by severity and graded according to the NCI CTCAE v5.0

Time frame
From first dose of study medication through 12 months after the last dose

Secondary outcomes

1

Tumor response

Assessment of response will be based on visual evaluation (cystoscopy), biopsy of remaining lesion (where technically feasible) and urine cytology.

Time frame
At 6 weeks after the last dose of study medication
2

Event-free survival

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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