Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma
Status:
Terminated
Trial end date:
2012-06-29
Target enrollment:
Participant gender:
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.