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NCT Number: NCT00168064

Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

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).

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Key information

Conditions

Mycosis Fungoides Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Medical Center, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechlorethamine-MCH (nitrogen mustard)

Drug

All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment

Other names: mechlorethamine, nitrogen mustard

Primary outcomes

  1. Ratio of Response Rates Based on CAILS

    Time frame: Assessment made at Day 1 and every subsequent visit during treatment

    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

Secondary outcomes

  1. 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

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

    Time frame: Baseline to end of therapy

    Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.

Sponsors and collaborators

Lead sponsor

Yaupon Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Sep 14, 2005
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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