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

Division Of Basic Sciences - Nci

Investigators

Abstract

We have been actively recruiting for this clinical trial protocol of the safety and efficacy of topical romidepsin (depsipeptide) in early stage mycosis fungoides (a rare type of skin lymphoma). In fiscal year 2009, we completed two dose levels. 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.