Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Mycosis Fungoides
About this trial
This is an interventional treatment trial for Mycosis Fungoides focused on measuring Mycosis Fungoides, Nitrogen Mustard, Cutaneous T-Cell Lymphoma, CTCL - Mycosis Fungoides
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Stanford University Medical Center
- Northwestern University - Dept. of Dermatology
- NYU Medical Center Dept. of Dermatology
- Columbia University, Dept. of Dermatology
- Duke University Medical Center
- Oklahoma University
- University of Pennsylvania
- Fox Chase Cancer Center
- University of Texas, Southwestern Medical Center
- The University of Texas, M.D. Anderson Cancer Center
- Utah Clinical Trials, LLC
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1 (PG - NM (MCH) 0.02%)
2 (AP - MCH(NM) 0.02%)
PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF
AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF