University of California, Davis
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.
PRIMARY OBJECTIVE: I. Evaluate the safety and tolerability of PPM administered through intravesical instillation. SECONDARY OBJECTIVES: I. Evaluate tumor response at 6 weeks after completion of PPM intravesical therapy. II. Assess event-free survival rate at 12 months. OUTLINE: Patients receive PPM intravesically over 1 hour once a week (QW) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET), and cystoscopy with biopsy at screening and follow up…
Inclusion Criteria: * 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 * Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as being at least one of the following: * Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary dis…
Given PLZ4-coated paclitaxel loaded micelles intravesically
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