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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yaupon Therapeutics
ClinicalTrials.gov Identifier:
NCT00535470
First received: September 24, 2007
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Mycosis Fungoides
Drug: 0.04% Mechlorethamine gel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yaupon Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: July 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nitrogen Mustard 0.04%

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535470

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Northwestern University-Dept. of Dermatology
Chicago, Illinois, United States, 61611
United States, New York
NYU Medical Center Dept. of Dermatology
New York, New York, United States, 10016
Columbia University, Dept of Dermatology
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oklahoma
Oklahoma University
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
University of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States, 84107
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53791
Sponsors and Collaborators
Yaupon Therapeutics
Investigators
Principal Investigator: Stuart Lessin, M.D. Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Yaupon Therapeutics
ClinicalTrials.gov Identifier: NCT00535470     History of Changes
Other Study ID Numbers: 2007NMMF-202-US
Study First Received: September 24, 2007
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mechlorethamine
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014