Microneedle 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

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 with the potential to simultaneously convert a cutaneous neoplasm into a highly potent patient specific immunogen capable of inducing innate, adaptive, and tumor specific effector and memory immune responses.

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.

Registro actualizado en ClinicalTrials.gov →

• Subjects must have a histological diagnosis of cSCC based upon a skin biopsy.
• Subjects must have resectable stage I-III disease.
• - Measures ≥5 millimeters (mm; post-biopsy) and <100 mm in longest diameter
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
• Subjects must have an expected survival of greater than or equal to 12 months.
• Subjects must not be on any other investigational device/drug treatment.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.