Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

Not Recruiting

Trial ID: NCT00168064


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).

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)

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology


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

   - 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


drug: mechlorethamine-MCH (nitrogen mustard)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Natalie Viakhireva

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