Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

Completed · Phase 2

Conditions studied: Mycosis Fungoides

In brief

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).

Key facts

Study ID

NCT00168064

Run by

Yaupon Therapeutics

People needed

260

Starts

2006-05-01

Expected to finish

2011-08-01

Last updated by the study team

2012-10-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with mycosis fungoides confirmed by a skin biopsy
• Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)
• Patients must be otherwise healthy with acceptable organ function.
• Prior to initiating study therapy, patients must not have had topical therapy within four weeks
• Lab values within normal range
• Willing/able to give consent
• Must use effective means of contraception if of childbearing potential

You may not qualify if…

• Newly diagnosed mycosis fungoides with no prior therapy
• A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)
• Use of topical or systemic therapies for MF within four (4) weeks of entry in the study
• Patients with a diagnosis of stage IIB-IV MF
• Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program
• Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
• Patients who have had radiation therapy within one year of study start
• Patients who have a history of a higher T score than T2 or a higher N score than N1
• Patients who do not agree to do all labs at one site

Where it is running

• 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

Full record on ClinicalTrials.gov

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