What side effects are associated with this type of intervention?

Common treatments for bladder cancer, particularly those involving paclitaxel, can have several side effects. Paclitaxel, a chemotherapy drug, is known to cause neuropathy, myelosuppression (leading to neutropenia), fatigue, and gastrointestinal issues such as nausea and diarrhea. Targeted delivery systems like the investigational PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM) aim to reduce these side effects by specifically targeting cancer cells, potentially minimizing systemic toxicity. However, the specific side effects of such targeted therapies are still being studied and may include localized bladder irritation or inflammation.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer, including chemotherapeutic agents and targeted therapies. One notable approval is for paclitaxel, a chemotherapy drug used in various formulations for cancer treatment. Additionally, the FDA has approved enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, for patients with advanced urothelial carcinoma. This drug exemplifies targeted delivery similar to the investigational PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM), which aims to deliver paclitaxel directly to bladder cancer cells. Other approved treatments include immune checkpoint inhibitors like pembrolizumab and atezolizumab, which enhance the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM) for bladder cancer patients include: 1) Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown efficacy in patients who have progressed after platinum-based chemotherapy and PD-1/PD-L1 inhibitors. 2) Sacituzumab govitecan, another antibody-drug conjugate targeting Trop-2, which has demonstrated activity in metastatic urothelial carcinoma after prior chemotherapy and immunotherapy. 3) Immune checkpoint inhibitors such as Atezolizumab and Pembrolizumab, which continue to be explored in various combinations and settings for advanced bladder cancer.

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Anti-metabolites

Intravesical PPM Therapy for Bladder Cancer

Phase 1

Recruiting

Led By Chong-Xian Pan, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Refusal or intolerance of a radical cystectomy recommended by the treating urologist as the standard next therapy per urologic guidelines

BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) or intolerance of treatment with BCG

Must not have

Women who are pregnant or nursing

Existence of cancer at the upper urinary tract

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 hours after administration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new bladder cancer treatment called PPM, which uses tiny particles to deliver a chemotherapy drug directly to cancer cells. It targets patients whose bladder cancer has not spread into the muscle and who did not respond to a previous treatment. The goal is to find the right dose and check for side effects and effectiveness.

Who is the study for?

This trial is for adults with bladder cancer that hasn't spread into the muscle and didn't respond to BCG treatment. Participants need good lung function, can't have severe heart issues or other serious illnesses, must not be pregnant or nursing, and should agree to use birth control. They should also have a life expectancy of more than 24 months.

What is being tested?

The trial tests PLZ4-coated paclitaxel-loaded micelles (PPM), designed to target bladder cancer cells specifically. PPM will be placed directly into the bladder in patients who haven’t responded well to prior treatments. The study aims to find the right dose for future trials and check its safety and early effectiveness.

What are the potential side effects?

Possible side effects may include typical chemotherapy-related issues like irritation at the instillation site within the bladder, allergic reactions, fatigue, nausea, low blood cell counts increasing infection risk, bleeding complications or potential harm to liver or kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot or will not undergo major bladder surgery as advised.

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My bladder cancer has not responded to BCG treatment or I cannot tolerate BCG.

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I cannot or will not undergo major bladder surgery as advised.

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I am 18 years old or older.

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I have completed the recommended BCG treatment.

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I am not currently undergoing, nor scheduled for, any cancer treatments.

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My lungs work well and I don't have serious breathing problems.

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My bladder cancer was confirmed by a biopsy within the last 3 months and a recent cystoscopy showed no deep muscle invasion.

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I have recovered from any major side effects of previous treatments.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

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My cancer is located in the upper part of my urinary system.

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I am currently on IV antibiotics for an infection.

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I have a brain condition that cannot be controlled with treatment.

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I have difficulty making decisions due to my health condition.

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I have a bleeding disorder or take medication that affects blood clotting.

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I have severe heart issues, including heart failure or irregular heartbeats.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 hours after administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 hours after administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 hours after administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

adverse events

Secondary study objectives

complete response rate

Other study objectives

blood paclitaxel concentration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I dose-escalation and expansion cohortExperimental Treatment1 Intervention

There are three doses at the dose escalation stage: Dose level I: paclitaxel (PTX) 25 mg or 0.5 mg/ml; Dose Level II: PTX 50 mg or 1.0 mg/ml; Dose Level III: PTX 75 mg or 1.5 mg/ml. At the expansion cohort, up to 12 patients will be recruited and treated with PPM at the PTX dose of 50 mg or 1.0 mg/ml to determine the efficacy.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The investigational treatment PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM) targets bladder cancer cells by using the molecule PLZ4 to deliver the chemotherapy drug paclitaxel directly to the cancer cells. This targeted approach aims to increase drug concentration in cancer cells while minimizing exposure to healthy tissues, thereby reducing side effects. Other common treatments include intravesical therapy with Bacillus Calmette-Guérin (BCG), which stimulates the immune system to attack cancer cells, and systemic chemotherapy, which kills rapidly dividing cells throughout the body. Targeted delivery systems like PPM are crucial for bladder cancer patients as they offer the potential for more effective treatment with fewer side effects, improving patient outcomes and quality of life.

[Preparation of paclitaxel-loaded and folic acid-modified poly (lactic-co-glycolic acid) nano-micelles and in vitro anticancer effect on cervical cancer HeLa cells].Vaginal delivery of paclitaxel via nanoparticles with non-mucoadhesive surfaces suppresses cervical tumor growth.Small-sized polymeric micelles incorporating docetaxel suppress distant metastases in the clinically-relevant 4T1 mouse breast cancer model.