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

August 7, 2012 updated by: Yaupon Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 61611
        • Northwestern University-Dept. of Dermatology
    • New York
      • New York, New York, United States, 10016
        • NYU Medical Center Dept. of Dermatology
      • New York, New York, United States, 10016
        • Columbia University, Dept of Dermatology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas, Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • The University of Texas, M.D. Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Utah Clinical Trials, LLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53791
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Open label 0.04% Mechlorethamine gel
Drug: 0.04% 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.
Other Names:
  • Nitrogen Mustard 0.04%

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome 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
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yaupon Therapeutics

Investigators

  • Principal Investigator: Stuart Lessin, M.D., Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 24, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007NMMF-202-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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