Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Remetinostat
Intervention description: Topical 1% remetinostat gel
Intervention MeSH terms: Benzoic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label, single-arm study
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine if 8 weeks of topical remetinostat applied
      three times daily will suppress Squamous Cell Carcinoma.
    

Eligibility criteria:

        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.