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Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

Information source: Yaupon Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycosis Fungoides

Intervention: mechlorethamine-MCH (nitrogen mustard) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Yaupon Therapeutics

Official(s) and/or principal investigator(s):
Stuart Lessin, M.D., Study Director, Affiliation: Fox Chase Cancer Center

Summary

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).

Clinical Details

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)

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

Primary outcome: Ratio of Response Rates Based on CAILS

Secondary outcome:

Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks

Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Stanford University Medical Center, Stanford, California 94305, United States

Northwestern University - Dept. of Dermatology, Chicago, Illinois 61611, United States

Columbia University, Dept. of Dermatology, New York, New York 10032, United States

NYU Medical Center Dept. of Dermatology, New York, New York 10016, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Oklahoma University, Tulsa, Oklahoma 74104, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

University of Texas, Southwestern Medical Center, Dallas, Texas 75390, United States

The University of Texas, M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Utah Clinical Trials, LLC, Salt Lake City, Utah 84107, United States

University of Wisconsin, Madison, Wisconsin 53791, United States

Additional Information

Related 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.

Starting date: May 2006
Last updated: October 2, 2012

Page last updated: August 23, 2015

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