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

Status:	Completed
Conditions:	Infectious Disease, Lymphoma
Therapuetic Areas:	Immunology / Infectious Diseases, Oncology
Healthy:	No
Age Range:	Any
Updated:	10/14/2017
Start Date:	July 2007
End Date:	March 2011

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

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.

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

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111