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Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
This study is currently recruiting participants.
Verified by Yaupon Therapeutics, August 2008
Sponsored by: Yaupon Therapeutics
Information provided by: Yaupon Therapeutics
ClinicalTrials.gov Identifier: NCT00168064
  Purpose

This study will evaluate the efficacy, tolerability and safety of the topical application of nitrogen mustard (NM) ointment formulations in patients with stage I or IIA mycosis fungoides (MF).


Condition Intervention Phase
Mycosis Fungoides
Drug: Nitrogen Mustard
Phase II

MedlinePlus related topics: Fungal Infections Lymphoma
Drug Information available for: Mechlorethamine Mechlorethamine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Yaupon Therapeutics:

Primary Outcome Measures:
  • Skin response determined by the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity-weighted assessment tool (SWAT) within up to 12 months by 2 or more consecutive observations over at least 4 weeks [ Time Frame: Assessment made at Day 1 and every subsequent visit during treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 118
Study Start Date: May 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 (NM 0.02% PG): Active Comparator
To evaluate the tolerability and safety of topical application of NM 0.02% ointment formulations in patients with stage I or IIA MF
Drug: Nitrogen Mustard
All affected areas (lesions) are to be treated once daily for twelve months with NM 0.02% PG or NM 0.02% AP ointment
2 (NM 0.02% AP): Active Comparator
To evaluate the tolerability and safety of topical application of NM 0.02% ointment formulations in patients with stage I or IIA MF.
Drug: Nitrogen Mustard
All affected areas (lesions) are to be treated once daily for twelve months with NM 0.02% PG or NM 0.02% AP ointment

Detailed Description:

The successful use of nitrogen mustard 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. Over the past 45 years, multiple investigators have demonstrated the safety and efficacy of topically applied NM in the treatment of mycosis fungoides. This study will evaluate the efficacy, tolerability and safety of topical application of NM ointment formulations in patients with stage I or IIA MF.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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.

Exclusion Criteria:

  • Newly diagnosed mycosis fungoides with no prior therapy
  • A prior history of treatment with topical NM 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168064

Contacts
Contact: Stuart Lessin, M.D. 215-728-2191 stuart.lessin@fccc.edu

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Youn Kim, M.D.     650-723-6316     younkim@stanford.edu    
United States, Illinois
Northwestern University - Dept. of Dermatology Recruiting
Chicago, Illinois, United States, 61611
Contact: Joan Guitart, M.D.     312-695-1413     j-guitart@northwestern.edu    
Contact: Miquel Pena, M.D.     312-695-4761     Miguel-pena@northwestern.edu    
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexa B. Kimball, M.D.     617-726-5066     akimball@partners.org    
Contact: Gaby Rolz-Cruz     617-525-8254     grolcruz@partners.org    
United States, New York
NYU Medical Center Dept. of Dermatology Recruiting
New York, New York, United States, 10016
Contact: Bruce Strober, M.D., Ph.D.     212-263-5244     strober@nyc.rr.com    
Columbia University, Dept. of Dermatology Recruiting
New York, New York, United States, 10032
Contact: Elizabeth Knobler, M.D.     212-305-7293        
Contact: Julian Mackay-Wiggin, M.D., M.S.     212-305-6953     jc299@columbia.edu    
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Elise A. Olsen, M.D.     919-668-5613     olsen001@mc.duke.edu    
United States, Oklahoma
Oklahoma University Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Mark F. Naylor, M.D.     918-743-4821     mark-naylor@ouhsc.edu    
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alain H. Rook, M.D.     215-662-7610     arook@mail.med.upenn.edu    
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Stuart Lessin, M.D.     215-728-2191     S_Lessin@fccc.edu    
Principal Investigator: Stuart Lessin, M.D.            
United States, Texas
The University of Texas, M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Madeleine Duvic, M.D.     713-745-4615     mduvic@mdanderson.org    
University of Texas, Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Christina Carrigan, R.N.     214-645-8968     Christina.Carrigan@UTSouthwestern.edu    
Principal Investigator: Amit G. Pandya, M.D.            
United States, Utah
Utah Clinical Trials, LLC Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Christopher B. Hansen, M.D.     801-268-1610     chansen@utahclinicaltrials.com    
Contact: Christopher D. Hansen, M.D.     801-268-1610     dhansen@utahclinicaltrials.com    
Principal Investigator: Christopher Hull, M.D.            
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53791
Contact: Gary Wood, M.D.     608-287-2620     gwood@dermatology.wisc.edu    
Contact: Ladan Mostaghimi, M.D.     608-287-2620        
Principal Investigator: Gary Wood, M.D.            
Sponsors and Collaborators
Yaupon Therapeutics
Investigators
Study Director: Stuart Lessin, M.D. Fox Chase Cancer Center, Philadelphia, PA
  More Information

Cutaneous Lymphoma Foundation  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Yaupon Therapeutics, Inc. ( Stuart R. Lessin, M.D., Principal Investigator )
Study ID Numbers: 2005NM-201-US
Study First Received: September 7, 2005
Last Updated: August 20, 2008
ClinicalTrials.gov Identifier: NCT00168064  
Health Authority: United States: Food and Drug Administration

Keywords provided by Yaupon Therapeutics:
Mycosis Fungoides
Nitrogen Mustard
Cutaneous T-Cell Lymphoma
CTCL - Mycosis Fungoides

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Sezary Syndrome
Mycosis Fungoides
Mycoses
Lymphatic Diseases
Lymphoma, T-Cell
Mechlorethamine
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Nitrogen Mustard Compounds
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009