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

Inclusion Criteria:

   1. Must have at least one biopsy-proven cutaneous SCC or SCC in situ (SCC-IS) lesion
   greater than or equal to 5 mm. Non-invasive SCC lesion(s), including Bowen's disease
   (SCC-IS), are eligible, but must be amenable to surgical resection.

   2. 18 years of age or older.

   3. Must be willing to apply the topical remetinostat 3 times daily for 8 weeks and cover
   with an occlusive bandage.

   4. Negative serum pregnancy test within 14 days prior to the first dose of study therapy
   for women of child-bearing potential, 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 (i.e., who has had menses any time in the preceding 24 consecutive
   months)

   5. Sexually active women of child bearing potential (WCBP) and male patients with a
   female partner of child-bearing potential must agree to use acceptable methods of
   contraception to avoid pregnancy (for example, oral, injectable, or implantable
   hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive
   with spermicide; or vasectomized partner) before the first dose of study therapy and
   for 3 months after the last dose of study therapy

   6. Has signed and dated the current, approved informed consent document.

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.

   3. SCC lesion(s) in cosmetically-sensitive areas (e.g. tip of nose, eyelid) are not
   eligible for enrollment. (If a patient has SCC lesion(s) in other areas, those
   tumor(s) may be considered for enrollment.)

   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.