Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

Exclusion Criteria

• •1. Any large (\> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection.
• •2. Inoperable locally-advanced and/or non-cutaneous metastatic SCC.
• •4. Taking any medication known to affect SCC growth
• •5. Within the past 6 months, has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically, these include the topical use at the site of the study tumors:
• •* Glucocorticoids
• •* Retinoids either systemically or topically at the tumor site (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
• •* Alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to the tumor site
• •* 5-fluorouracil or imiquimod
• •6. Has received treatment with systemic chemotherapy within 60 days prior to starting study medication.
• •7. Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
• •8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements.
• •9. Moderate to significant immunosuppression (e.g., active cancer, significant autoimmune disease) and/or receiving immunosuppressive drugs that result in moderate to significant immunosuppression (e.g. low dose oral glucocorticoids do not necessarily exclude a patient)
• •10. Known or previous hypersensitivity to HDACi
• •11. History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction.
• •12. Pregnancy or breast-feeding.