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)

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