Clinical Trial: An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

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

Official Title: An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Ha

Brief Summary: To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.

Detailed Summary: This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.
Sponsor: Yaupon Therapeutics

Current Primary Outcome: Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF [ Time Frame: 7 months ]

Original Primary Outcome:

Current Secondary Outcome: Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF [ Time Frame: 7 months ]

Original Secondary Outcome:

Information By: Yaupon Therapeutics

Dates:
Date Received: September 24, 2007
Date Started: July 2007
Date Completion:
Last Updated: August 7, 2012
Last Verified: August 2012