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Brief Title: Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Official Title: A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)
Study ID: NCT03875859
Brief 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.
Detailed Description: The primary purpose of this study is: * to determine if 8 weeks of topical remetinostat gel applied 3 times daily (TID) under occlusion will suppress SCC growth * to determine the overall response rate (ORR) of SCCs after 8 weeks of treatment with topical remetinostat gel 1%, as measured by at least 30% decrease in greatest area (in mm2). * Subjects with at least 1 biopsy-proven cutaneous SCC will be recruited for this study. * Subjects will apply remetinostat gel 1% to at least 1 SCC. * Non-invasive cutaneous SCC lesions, including Bowen's disease, are also eligible for this study * There is 1 treatment option: Topical remetinostat gel 1% applied 3 times daily. * The study is a single arm, open label design * For purposes of ClinicalTrials.gov, there is no secondary outcome.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Medical Center, Stanford, California, United States
Name: Kavita Y Sarin, MD, PhD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR