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

Yaupon Therapeutics100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Mycosis Fungoides

Interventions

0.04% Mechlorethamine gelDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (11)

Stanford University Medical Center

Stanford, California, United States

Northwestern University-Dept. of Dermatology

Chicago, Illinois, United States

Columbia University, Dept of Dermatology

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 7 months

Secondary Outcomes

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

Time frame: 7 months

Data from ClinicalTrials.gov

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