Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides - Full Text View

Sponsor:	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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Mechlorethamine hydrochloride

U.S. FDA Resources

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:	250
Study Start Date:	May 2006
Estimated Study Completion Date:	July 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 (NM 0.02% PG) 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
Active Comparator: 2 (NM 0.02% AP) 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. Since then, 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168064

Locations

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Northwestern University - Dept. of Dermatology
Chicago, Illinois, United States, 61611
United States, New York
NYU Medical Center Dept. of Dermatology
New York, New York, United States, 10016
Columbia University, Dept. of Dermatology
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
Oklahoma University
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53791

Sponsors and Collaborators

Yaupon Therapeutics

Investigators

Study Director:

Stuart Lessin, M.D.

Fox Chase Cancer Center

More Information

Additional Information:

Cutaneous Lymphoma Foundation This link exits the ClinicalTrials.gov site

Publications:

Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73.

Kim YH. Management with topical nitrogen mustard in mycosis fungoides. Dermatol Ther. 2003;16(4):288-98. Review.

Kim YH, Jensen RA, Watanabe GL, Varghese A, Hoppe RT. Clinical stage IA (limited patch and plaque) mycosis fungoides. A long-term outcome analysis. Arch Dermatol. 1996 Nov;132(11):1309-13.

Responsible Party:	Stuart R. Lessin, M.D., Principal Investigator, Yaupon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00168064 History of Changes
Other Study ID Numbers:	2005NM-201-US
Study First Received:	September 7, 2005
Last Updated:	November 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yaupon Therapeutics:

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

Additional relevant MeSH terms:

Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Mechlorethamine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012