Phase I Study of Topical Romidepsin in Early Stage Cutaneous T-cell Lymphoma

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In this clinical trial protocol of the safety and efficacy of topical romidepsin (depsipeptide) in early stage mycosis fungoides (a rare type of skin lymphoma), each dose level evaluation includes repeated assessments of skin disease through physical examination, medication tolerability, pruritus, quality of life, erythema with the use of colorimeter, photography using a standardized studio set-up, research blood for side effect evaluation and pharmacokinetics, and skin biopsies for routine histology and special research studies. We encountered a dose limiting skin toxicity within this fiscal year. As a result, we worked on recruiting additional subjects for that dose level. However, due to technical issues in the immunohistochemistry assays indicating uncertainty regarding inhibition of histone deacetylase, further recruitment has been temporarily held. We have been working with collaborators and CTEP to resolve these technical issues prior to further enrollment.