Back to resultsAn Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
Primary Purpose
Mycosis Fungoides
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.04% Mechlorethamine gel
Sponsored by
About this trial
This is an interventional treatment trial for Mycosis Fungoides
Eligibility 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
Sites / Locations
- Stanford University Medical Center
- Northwestern University-Dept. of Dermatology
- Columbia University, Dept of Dermatology
- NYU Medical Center Dept. of Dermatology
- Duke University Medical Center
- Oklahoma University
- Fox Chase Cancer Center
- University of Texas, Southwestern Medical Center
- The University of Texas, M.D. Anderson Cancer Center
- Utah Clinical Trials, LLC
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Open label 0.04% Mechlorethamine gel
Outcomes
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00535470
Brief Title
An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yaupon Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Open label 0.04% Mechlorethamine gel
Intervention Type
Drug
Intervention Name(s)
0.04% Mechlorethamine gel
Other Intervention Name(s)
Nitrogen Mustard 0.04%
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Lessin, M.D.
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northwestern University-Dept. of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
61611
Country
United States
Facility Name
Columbia University, Dept of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Medical Center Dept. of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Oklahoma University
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
University of Texas, Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Clinical Trials, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53791
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35536441
Citation
Querfeld C, Scarisbrick JJ, Assaf C, Kim YH, Guitart J, Quaglino P, Hodak E. Chlormethine Gel Versus Chlormethine Ointment for Treatment of Patients with Mycosis Fungoides: A Post-Hoc Analysis of Clinical Trial Data. Am J Clin Dermatol. 2022 Jul;23(4):561-570. doi: 10.1007/s40257-022-00687-y. Epub 2022 May 10.
Results Reference
derived
Learn more about this trial
An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides
We'll reach out to this number within 24 hrs