Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma

Summary

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.

Timeline

Start

2007-04-21

Primary completion

—

Completion

2012-06-29

Publications

• Background Ueda H, Nakajima H, Hori Y, Goto T, Okuhara M. Action of FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum no. 968, on Ha-ras transformed NIH3T3 cells. Biosci Biotechnol Biochem. 1994 Sep;58(9):1579-83. doi: 10.1271/bbb.58.1579.
• Background Kitazono M, Chuman Y, Aikou T, Fojo T. Construction of gene therapy vectors targeting thyroid cells: enhancement of activity and specificity with histone deacetylase inhibitors and agents modulating the cyclic adenosine 3',5'-monophosphate pathway and demonstration of activity in follicular and anaplastic thyroid carcinoma cells. J Clin Endocrinol Metab. 2001 Feb;86(2):834-40. doi: 10.1210/jcem.86.2.7196.
• Background Ueda H, Manda T, Matsumoto S, Mukumoto S, Nishigaki F, Kawamura I, Shimomura K. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. III. Antitumor activities on experimental tumors in mice. J Antibiot (Tokyo). 1994 Mar;47(3):315-23. doi: 10.7164/antibiotics.47.315.

Drugs

Indications