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

Sponsor

Yaupon Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00535470

Collaborator

(none)

100

Enrollment

Locations

Arm

Duration (Months)

9.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mycosis Fungoides	Drug: 0.04% Mechlorethamine gel	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Open label 0.04% Mechlorethamine gel	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. Other Names: Nitrogen Mustard 0.04%

Arm

Intervention/Treatment

Experimental: 1

Open label 0.04% Mechlorethamine gel

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.

Other Names:

Nitrogen Mustard 0.04%

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Stanford	California	United States	94305
2	Northwestern University-Dept. of Dermatology	Chicago	Illinois	United States	61611
3	Columbia University, Dept of Dermatology	New York	New York	United States	10016
4	NYU Medical Center Dept. of Dermatology	New York	New York	United States	10016
5	Duke University Medical Center	Durham	North Carolina	United States	27710
6	Oklahoma University	Tulsa	Oklahoma	United States	74104
7	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
8	University of Texas, Southwestern Medical Center	Dallas	Texas	United States	75390
9	The University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77030
10	Utah Clinical Trials, LLC	Salt Lake City	Utah	United States	84107
11	University of Wisconsin	Madison	Wisconsin	United States	53791

Sponsors and Collaborators

Yaupon Therapeutics

Investigators

Principal Investigator: Stuart Lessin, M.D., Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yaupon Therapeutics

ClinicalTrials.gov Identifier:

NCT00535470

Other Study ID Numbers:

2007NMMF-202-US

First Posted:

Sep 26, 2007

Last Update Posted:

Aug 9, 2012

Last Verified:

Aug 1, 2012

Additional relevant MeSH terms:

Mycoses

Mycosis Fungoides

Mechlorethamine

Study Results

No Results Posted as of Aug 9, 2012