A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)
The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis
fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and
provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since
then, multiple investigators have demonstrated the safety and efficacy of topically applied
MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy
(non-inferiority), tolerability and safety of topical application of MCH proprietary gel
versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Ratio of Response Rates Based on CAILS
The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment
Assessment made at Day 1 and every subsequent visit during treatment
No
Stuart Lessin, M.D.
Study Director
Fox Chase Cancer Center
United States: Food and Drug Administration
2005NMMF-201-US
NCT00168064
May 2006
August 2011
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Northwestern University - Dept. of Dermatology | Chicago, Illinois 61611 |
NYU Medical Center Dept. of Dermatology | New York, New York 10016 |
Columbia University, Dept. of Dermatology | New York, New York 10032 |
Oklahoma University | Tulsa, Oklahoma 74104 |
University of Texas, Southwestern Medical Center | Dallas, Texas 75390 |
The University of Texas, M.D. Anderson Cancer Center | Houston, Texas 77030 |
Utah Clinical Trials, LLC | Salt Lake City, Utah 84107 |