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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535470

Enrollment

100

Registered

2007-09-26

Start date

2007-07-31

Completion date

2011-03-31

Last updated

2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycosis Fungoides

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.

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.

Interventions

DRUG0.04% 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026