Phase I Study of Topical Romidepsin (Depsipeptide) in Early Stage Cutaneous T-Cell Lymphoma

Background:

• Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The cancer cells are found in red, scaly patches that may sometimes itch.
• Early-stage CTCL is usually treated with topical therapies, which may lose effectiveness over time and have adverse effects, such as risk of secondary skin cancers and difficulty of use.
• Romidepsin is an experimental drug that, given through a vein, has improved CTCL in some patients with later stages of the disease.
• A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.

Objectives:

• To determine the highest tolerated dose of topical romidepsin that can be given to patients with early-stage CTCL.
• To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.
• To determine how the body handles topical romidepsin.

Eligibility:

-Patients 18 of age and older with early-stage CTCL.

Design:

• Study Part 1: Successive groups of 3 patients are treated with increasingly higher concentrations of topical romidepsin until the highest tolerated dose is found.
• Study Part II: The highest tolerated dose, as determined in Part I, is applied to larger areas of skin in another group of patients.
• All study participants apply the study medicine to their skin three times a day for 4 weeks.
• During treatment, participants are monitored at weeks 2 and 4 with a history and physical examination, blood tests, electrocardiogram, skin biopsies and photographs of the skin.
• After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood tests and to see how the study medication is affecting the body.