Clinical Trial: Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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)

Brief 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).

Detailed Summary: 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.
Sponsor: Yaupon Therapeutics

Current Primary Outcome: 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


Original Primary Outcome: Skin response determined by the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment.

Current Secondary Outcome:

  • 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 ]
  • 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.


Original Secondary Outcome:

  • Severity-Weighted Assessment Tool (SWAT) within up to 12 months by 2 or more consecutive observations over at least 4 weeks.
  • Spitzer 5 item General Status Patient Questionnaire
  • Patient Visual Analog scale
  • MF-Specific Patient Questionnaire


Information By: Yaupon Therapeutics

Dates:
Date Received: September 7, 2005
Date Started: May 2006
Date Completion:
Last Updated: October 2, 2012
Last Verified: October 2012