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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)

Phase 2
Not Enrolling
Mycosis Fungoides

Thank you

Trial Information

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)

The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis
fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and
provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since
then, multiple investigators have demonstrated the safety and efficacy of topically applied
MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy
(non-inferiority), tolerability and safety of topical application of MCH proprietary gel
versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Ratio of Response Rates Based on CAILS

Outcome Description:

The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment

Outcome Time Frame:

Assessment made at Day 1 and every subsequent visit during treatment

Safety Issue:


Principal Investigator

Stuart Lessin, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

August 2011

Related Keywords:

  • Mycosis Fungoides
  • Mycosis Fungoides
  • Nitrogen Mustard
  • Cutaneous T-Cell Lymphoma
  • CTCL - Mycosis Fungoides
  • Mycoses
  • Mycosis Fungoides



Stanford University Medical CenterStanford, California  94305-5408
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
University of WisconsinMadison,, Wisconsin  53792-5666
Northwestern University - Dept. of DermatologyChicago, Illinois  61611
NYU Medical Center Dept. of DermatologyNew York, New York  10016
Columbia University, Dept. of DermatologyNew York, New York  10032
Oklahoma UniversityTulsa, Oklahoma  74104
University of Texas, Southwestern Medical CenterDallas, Texas  75390
The University of Texas, M.D. Anderson Cancer CenterHouston, Texas  77030
Utah Clinical Trials, LLCSalt Lake City, Utah  84107