NCT00168064

Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Yaupon Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	mechlorethamine-MCH (nitrogen mustard)	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

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2005-09-14
• Last updated: 2012-10-31
• Results posted: 2012-10-31

Locations

12 sites across 1 country: United States