Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma
Stopped early · Phase 1
Conditions studied: Mycosis Fungoides, Cutaneous T-Cell Lymphoma, Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01445340
- Run by
- National Cancer Institute (NCI)
- People needed
- 6
- Starts
- 2007-04-21
- Expected to finish
- 2012-06-29
- Last updated by the study team
- 2019-12-17
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Prior or concurrent malignancies that have not been curatively treated with the exception of malignancies that have been curatively treated and without recurrence in the preceding 5 years, non-melanoma skin cancers, low grade cervical cancer and prostate cancer.
- Current or previous CNS metastasis.
- Chemotherapy within 4 weeks, 6 weeks for nitrosoureas or mitomycin C, and 8 weeks for UCN-01.
- HIV seropositivity.
- Pregnant or breast-feeding patients.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Use of known CYP3A4 inhibitors within 3 days prior to receiving romidepsin ointment treatment.
- Inclusion of Women and Minorities:
- Subjects from both genders and all racial/ethnic groups are eligible for this study if they meet the eligibility criteria.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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