Falo, Louis, MD
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.
This study will evaluate a novel approach to the treatment of cutaneous squamous cell cancer (cSCC) of patients diagnosed previously by skin biopsy with cSCC utilizing a dissolvable microneedle array (MNA) delivery device that is used to directly and specifically deliver a drug to the tumor microenvironment for skin cancer therapy. The investigators will utilize MNAs to deliver a well-characterized, potent chemotherapeutic agent (doxorubicin) to kill topically accessible, cutaneous SCC cells. In addition to directly killing cancer cells, doxorubicin is known to induce an immunologic cell death…
Inclusion Criteria: 1. Subjects must have a histological diagnosis of cSCC based upon a skin biopsy. 2. Subjects must have resectable stage I-III disease. \- Measures ≥5 millimeters (mm; post-biopsy) and \<100 mm in longest diameter 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 4. Subjects must have an expected survival of greater than or equal to 12 months. 5. Subjects must not be on any other investigational device/drug treatment. 6. Subjects must be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consen…
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
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