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

Mycosis Fungoides Clinical Trial

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 Have Completed 12 Months Treatment Without a Complete Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535470
• Other study ID #: 2007NMMF-202-US
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2007
• Last updated: August 7, 2012
• Start date: July 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Yaupon Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• 0.04% Mechlorethamine gel
Mechlorethamine 0.04% PG applied to affected skin areas (lesions) once daily for up to seven (7) months. The frequency of application may be adjusted for toxicity. After seven (7) months, they will be terminated from the study.

Locations

Country	Name	City	State
United States	Northwestern University-Dept. of Dermatology	Chicago	Illinois
United States	University of Texas, Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	The University of Texas, M.D. Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin	Madison	Wisconsin
United States	Columbia University, Dept of Dermatology	New York	New York
United States	NYU Medical Center Dept. of Dermatology	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Utah Clinical Trials, LLC	Salt Lake City	Utah
United States	Stanford University Medical Center	Stanford	California
United States	Oklahoma University	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Yaupon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the tolerability and safety of topical application of NM 0.04% ointment formulations in patients with stage I or IIA MF		7 months