Spots Global Cancer Trial Database for Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
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Trial Identification
Brief Title: Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Official Title: 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)
Study ID: NCT00168064
Conditions
Interventions
Study Description
Brief Summary: This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University Medical Center, Stanford, California, United States
Northwestern University - Dept. of Dermatology, Chicago, Illinois, United States
NYU Medical Center Dept. of Dermatology, New York, New York, United States
Columbia University, Dept. of Dermatology, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Oklahoma University, Tulsa, Oklahoma, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Texas, Southwestern Medical Center, Dallas, Texas, United States
The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States
Utah Clinical Trials, LLC, Salt Lake City, Utah, United States
University of Wisconsin, Madison, Wisconsin, United States
Contact Details
Name: Stuart Lessin, M.D.
Affiliation: Fox Chase Cancer Center
Role: STUDY_DIRECTOR
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