RecruitingPhase 1Phase 2NCT05377905

Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)

Phase Ib/II Study of Micro-needle Array Containing Doxorubicin in Immune Competent or Immune-suppressed Patients With Cutaneous Squamous Cell Carcinoma


Sponsor

Falo, Louis, MD

Enrollment

48 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test a new method of experimental treatment for cutaneous squamous cell skin cancer, using small adhesive-like patches (a micro-needle applicator or MNA for short), which have dozens of very small micro-needles loaded with extremely low doses of doxorubicin, a chemotherapy agent. The overall goal of this study is to test the safety and effectiveness of these patches. The investigators have established the highest tolerated dose at 50 micrograms in a previous study for a different type of cancer that affects the skin. The investigators will thoroughly evaluate the skin where the patches are applied.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new way to deliver chemotherapy directly into skin cancer tumors using a device called a microneedle array — tiny needles that painlessly deliver the drug doxorubicin right into the tumor — for people with a type of skin cancer called cutaneous squamous cell carcinoma (cSCC). **You may be eligible if...** - You have a confirmed skin cancer diagnosis of cSCC (cutaneous squamous cell carcinoma) - Your cancer is Stage I to III and can be surgically removed - Your tumor is at least 5 mm in its longest dimension and smaller than 100 mm - You are reasonably active overall (ECOG performance 0–2) and expected to live at least 12 more months - Your blood counts and kidney function are within acceptable ranges **You may NOT be eligible if...** - You are on other experimental drugs or devices - Your blood counts (neutrophils, platelets) or kidney/liver function are too low - You have another active serious illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMicroneedle Array Doxorubicin (MNA-D)

The Microneedle array patch is loaded/prepared with a total dose of 50 micrograms of Doxorubicin and is applied to a single selected cSCC remnant for a period of 20 minutes for a total of 4 weekly applications


Locations(1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

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NCT05377905


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