Drug Screening of Cutaneous Lesions of Squamous Cell Carcinoma

Conditions

Microdevice — COMBINATION_PRODUCT
Device: Microdevices The microdevice is an investigational miniaturized implantable nanodose drug delivery device. It was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer. The microdevice releases nanodoses of several approved drugs into the tumor, and is then excised minimally invasively several days later. Other: Standard of care therapy Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy

This research study is studying the effect of different drugs as possible treatments for squamous cell carcinoma (SCC).

Experimental: Local treatment cohort
Local Treatment Cohort (5 participants) may recruit participants who plan to receive local surgical intervention (Mohs surgery or local excision) alone or in combination with further surgical treatment, radiation, or systemic therapy.
Experimental: Systemic treatment cohort
Systemic Treatment Cohort (20 patients) will not enroll until initial cohort has been completed (MD have been implanted, retrieved, and processed for immunohistochemical analysis). Microdevice protocol will be optimized given results derived from the local treatment cohort. Will include participants who plan to receive systemic therapy in the absence of additional local therapy (surgery or radiation). If patients receive systemic therapy, and there is clinical cutaneous residual disease after 12 weeks of systemic therapy, an additional 1 to 4 MDs will be implanted into residual cutaneous disease at this time.

Feasibility of analysis [ Time Frame: through study completion, an average of 1 year ]

Facility	City	State	ZIP	Site coordinators
Dana Farber Cancer Insitute	Boston	Massachusetts	02115	-

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