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

Phase 2

Completed

• Conditions: Mycosis Fungoides
• Interventions: Drug: 0.04% Mechlorethamine gel

• Registration Number: NCT00535470
• Lead Sponsor: Yaupon Therapeutics

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 Description

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not achieved a complete response.

Exclusion Criteria

• Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	0.04% Mechlorethamine gel	Open label 0.04% Mechlorethamine gel

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of topical application of NM 0.04% in a propylene glycol ointment (PG) in patients with stage I or IIA MF	7 months

Secondary Outcome Measures

Name	Time	Method
Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF	7 months

Trial Locations

Locations (11)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Columbia University, Dept of Dermatology; 🇺🇸 New York, New York, United States

Northwestern University-Dept. of Dermatology; 🇺🇸 Chicago, Illinois, United States

NYU Medical Center Dept. of Dermatology; 🇺🇸 New York, New York, United States

Oklahoma University; 🇺🇸 Tulsa, Oklahoma, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Texas, Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Utah Clinical Trials, LLC; 🇺🇸 Salt Lake City, Utah, United States

The University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States