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

Oklahoma University

1725 E 19th St # Ll103
Tulsa, Oklahoma 74104

from

Tulsa, OK