Topical Remetinostat Gel before Surgery for the Treatment of Skin Squamous Cell Cancer

Inclusion Criteria

• Must have at least one cutaneous SCC or SCC in situ lesion greater than or equal to 5 mm. Non invasive SCC lesion(s), including (SCC in situ [IS]), are eligible, but must be amenable to surgical resection
• Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover with an occlusive bandage
• Negative serum pregnancy test within 14 days prior to the first dose of study therapy (for women of child bearing potential [WCBP], defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [e.g., who has had menses any time in that period])
• Sexually active women of child bearing potential and male patients with a female partner of child bearing potential must agree to use acceptable methods of contraception to avoid pregnancy (e.g., oral; injectable; or implantable hormonal contraceptive; tubal ligation; intra uterine device; barrier contraceptive with spermicide; or vasectomized male) before the 1st dose of study therapy and for 3 months after the last dose of study therapy
• Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

Exclusion Criteria

• Any large (> 20 mm) SCC lesion. Patients with large SCC lesion(s) will be referred for evaluation for surgical resection
• Inoperable locally advanced and/or non cutaneous metastatic SCC
• SCC lesion(s) in cosmetically sensitive areas (e.g., tip of nose, eyelid). If a prospective subject has SCC lesion(s) in other areas, those tumor(s) may be considered for enrollment
• Taking any medication known to affect SCC growth
• 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
• Has received treatment with systemic chemotherapy within 60 days prior to starting study medication
• Currently receiving systemic medications that could affect SCC tumors (e.g., oral retinoids) or might interact with remetinostat
• 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
• 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)
• Known or previous hypersensitivity to histone deacetylase inhibitors (HDACi)
• History of congestive heart failure, cardiac arrhythmias, or other findings of ventricular dysfunction
• Pregnancy or breast feeding