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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


Phase 2
N/A
N/A
Not Enrolling
Both
Mycosis Fungoides

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

7 months

Safety Issue:

Yes

Principal Investigator

Stuart Lessin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2007NMMF-202-US

NCT ID:

NCT00535470

Start Date:

July 2007

Completion Date:

March 2011

Related Keywords:

  • Mycosis Fungoides
  • Mycoses
  • Mycosis Fungoides

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Duke University Medical Center Durham, North Carolina  27710
University of Wisconsin Madison,, Wisconsin  53792-5666
NYU Medical Center Dept. of Dermatology New York, New York  10016
Oklahoma University Tulsa, Oklahoma  74104
University of Texas, Southwestern Medical Center Dallas, Texas  75390
The University of Texas, M.D. Anderson Cancer Center Houston, Texas  77030
Utah Clinical Trials, LLC Salt Lake City, Utah  84107
Northwestern University-Dept. of Dermatology Chicago, Illinois  61611
Columbia University, Dept of Dermatology New York, New York  10016