Status:
COMPLETED
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Lead Sponsor:
Yaupon Therapeutics
Conditions:
Mycosis Fungoides
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).
Detailed Description
The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rational...
Eligibility Criteria
Inclusion
- Patients with mycosis fungoides confirmed by a skin biopsy
- Stage I or IIA patients must have been treated previously with prior topical therapies including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical carmustine (BCNU)
- Patients must be otherwise healthy with acceptable organ function.
- Prior to initiating study therapy, patients must not have had topical therapy within four weeks
- Lab values within normal range
- Willing/able to give consent
- Must use effective means of contraception if of childbearing potential
Exclusion
- Newly diagnosed mycosis fungoides with no prior therapy
- A prior history of treatment with topical NM within the past 2 years or topical carmustine (BCNU)
- Use of topical or systemic therapies for MF within four (4) weeks of entry in the study
- Patients with a diagnosis of stage IIB-IV MF
- Serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program
- Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
- Patients who have had radiation therapy within one year of study start
- Patients who have a history of a higher T score than T2 or a higher N score than N1
- Patients who do not agree to do all labs at one site
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00168064
Start Date
May 1 2006
End Date
August 1 2011
Last Update
October 31 2012
Active Locations (12)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Northwestern University - Dept. of Dermatology
Chicago, Illinois, United States, 61611
3
NYU Medical Center Dept. of Dermatology
New York, New York, United States, 10016
4
Columbia University, Dept. of Dermatology
New York, New York, United States, 10032