Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
NCT ID: NCT00168064
Last Updated: 2012-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2006-05-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 (PG - NM (MCH) 0.02%)
PG - mechlorethamine-MCH (nitrogen mustard) 0.02% gel To evaluate the tolerability and safety of topical mechlorethamine-MCH (nitrogen mustard) 0.02% ointment formulations in patients with stage I or IIA MF
mechlorethamine-MCH (nitrogen mustard)
All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
2 (AP - MCH(NM) 0.02%)
AP - mechlorethamine-MCH (nitrogen mustard) 0.02% compounded in Aquaphor To evaluate the tolerability and safety of mechlorethamine-MCH (nitrogen mustard)0.02% ointment formulations in patients with stage I or IIA MF
mechlorethamine-MCH (nitrogen mustard)
All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
Interventions
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mechlorethamine-MCH (nitrogen mustard)
All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
ALL
No
Sponsors
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Yaupon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Lessin, M.D.
Role: STUDY_DIRECTOR
Fox Chase Cancer Center
Locations
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Stanford University Medical Center
Stanford, California, United States
Northwestern University - Dept. of Dermatology
Chicago, Illinois, United States
NYU Medical Center Dept. of Dermatology
New York, New York, United States
Columbia University, Dept. of Dermatology
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oklahoma University
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States
Utah Clinical Trials, LLC
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73. doi: 10.1001/archderm.139.2.165.
Kim YH. Management with topical nitrogen mustard in mycosis fungoides. Dermatol Ther. 2003;16(4):288-98. doi: 10.1111/j.1396-0296.2003.01640.x.
Kim YH, Jensen RA, Watanabe GL, Varghese A, Hoppe RT. Clinical stage IA (limited patch and plaque) mycosis fungoides. A long-term outcome analysis. Arch Dermatol. 1996 Nov;132(11):1309-13.
Geskin LJ, Angello JT, Bagot M, Guenova E, Nikbakht N, Querfeld C, Scarisbrick JJ. Evaluating Response Trends of Chlormethine/Mechlorethamine Gel in Patients With Stage I-IIA Mycosis Fungoides: Analysis of Individual Patient Data From a Randomized Controlled Phase II Study to Facilitate Optimal Treatment Experiences. Clin Lymphoma Myeloma Leuk. 2024 Jan;24(1):40-47. doi: 10.1016/j.clml.2023.08.020. Epub 2023 Sep 7.
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.
Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, Bagot M, Ortiz-Romero PL, Quaglino P, Bonizzoni E, Hodak E. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Dermatology. 2022;238(2):347-357. doi: 10.1159/000516138. Epub 2021 Jun 4.
Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541.
Other Identifiers
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2005NMMF-201-US
Identifier Type: -
Identifier Source: org_study_id