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)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


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

New Trial Alerts

Receive email alerts when trials open to patients.