Microneedle Array Plus Doxorubicin in Cutaneous Squamous Cell Cancer (cSCC)
Trial Parameters
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Brief 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 Criteria
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 Consent Form prior to entry into the study. 7. Subjects must have the following pretreatment laboratory parameters: granulocytes ≥1,500/mm3; platelets \>50,000/mm3; serum creatinine ≤2X the upper limit of normal (ULN); AST, ALT ≤3X the ULN, bilirubin ≤1.5X ULN unless Gilbert's disease then ≤3X ULN. 8. Subjects must be at least 18 years of age and must be able to understand the written informed consent/assent