Clinical trial · Interventional
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)
NCT00168064CI-TRIAL-00008382completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mechlorethamine-MCH (nitrogen mustard) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1 (PG - NM (MCH) 0.02%)
- description
- 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
- interventionNames
- Drug: mechlorethamine-MCH (nitrogen mustard)
- type
- ACTIVE_COMPARATOR
- label
- 2 (AP - MCH(NM) 0.02%)
- description
- 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
- interventionNames
- Drug: mechlorethamine-MCH (nitrogen mustard)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (7)
- BACKGROUNDKim 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. PMID 12588222
- BACKGROUNDKim 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. PMID 14686971
- BACKGROUNDKim 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. PMID 8915308
- DERIVEDGeskin 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. PMID 37802679
- DERIVEDQuerfeld 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. PMID 35536441
- DERIVEDQuerfeld 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. PMID 34091453
- DERIVEDLessin 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.