Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer

PRIMARY OBJECTIVES:

I. Overall response rate of basal cell carcinoma (BCC) in subjects at 6 weeks.

SECONDARY OBJECTIVES:

I. Suppression of GLI1 (glioma-associated oncogene) expression in treated BCCs as compared with baseline.

II. Safety assessment of Remetinostat after 6 weeks of topical treatment.

OUTLINE:

Tumors receive Remetinostat topically three times per day (TID) for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for at least 4 weeks.

Inclusion criteria

• Must have at least one BCC lesion > 1 cm (BCC > 5 mm) in non-cosmetically sensitive site(s)
• Must be willing to apply the topical remetinostat 3 times daily for 6 weeks
• For women of child bearing potential, a negative urine pregnancy test
• Women of child bearing potential are expected to use an effective method of birth control while participating in the study and for 1 month after applying the last dose
• For male subjects with female partners of childbearing potential, agreement to use adequate contraception while participating in the study and for 1 month after applying the last dose
• Has signed and dated the current Institutional Review Board (IRB) approved informed consent document

Exclusion criteria

• Taking any medication known to interact with histone deacetylase (HDAC) inhibitors, such as valproate or anticoagulants
• Taking any medication known to affect hedgehog (HH) signaling pathway such as itraconazole
• 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 to the study tumors of:

• Glucocorticoids
• Retinoids either systemically or topically (eg, etretinate, isotretinoin, tazarotene, tretinoin, adapalene)
• Alpha hydroxy acids (eg, glycolic acid, lactic acid) to > 5% of the skin
• 5 fluorouracil or imiquimod and/or
• Itraconazole
• Has received treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling, within 60 days to starting study medication
• Currently receiving systemic medications that could affect BCC tumors (eg, 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 severe immunosuppression due to disease or medication
• Known or previous hypersensitivity to histone deacetylase inhibitor (HDACi)
• History of congestive heart failure; cardiac arrhythmias; or other findings of ventricular dysfunction
• History of current evidence of malabsorption or liver disease
• Pregnancy or breast feeding