Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides

Demierre, Marie‐France; Vachon, Luc; Ho, Vincent; Sutton, Lynda; Cato, Allen; Leyland‐Jones, Brian

doi:10.1001/archderm.139.5.624

Cited by 24 publications

(18 citation statements)

References 21 publications

(20 reference statements)

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“…28 Given the issues with cutaneous absorption, no commercially available topical MTX exists, making this treatment modality difficult to replicate; however, a previous phase 1/2 trial of a topical MTX-laurocapram topical hydrophilic gel did show some efficacy in CTCL, and similar compounds may hold promise for the future. 29 Bexarotene Bexarotene is an oral retinoid with a high affinity for the retinoid X receptor (RXR). It was approved by the US Food and Drug Administration (FDA) for the treatment of CTCL in 1999.…”

Section: Phototherapymentioning

confidence: 99%

Practical Management of CD30+ Lymphoproliferative Disorders

Hughey

2015

Dermatologic Clinics

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Primary cutaneous CD30⁺ lymphoproliferative disorders (LPDs) account for approximately 25% of cutaneous lymphomas. Although these LPDs are clinically heterogeneous, they can be indistinguishable histologically. Lymphomatoid papulosis rarely requires systemic treatment; however, multifocal primary cutaneous anaplastic large cell cutaneous lymphoma and large cell transformation of mycosis fungoides are typically treated systemically. As CD30⁺ LPDs are rare, there is little published evidence to support a specific treatment algorithm. Most studies are case reports, small case series, or retrospective reviews. This article discusses various treatment choices for each of the CD30⁺ disorders and offers practical pearls to aid in choosing an appropriate regimen.

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Section: Phototherapymentioning

confidence: 99%

Practical Management of CD30+ Lymphoproliferative Disorders

Hughey

2015

Dermatologic Clinics

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“…No systemic reactions or clinically significant laboratory abnormalities were observed. Serum levels of MTX, as measured 24-48 h following the topical application, were under the lowest limit of detection in all samples analysed [13] .…”

Section: Methotrexatementioning

confidence: 84%

“…Demierre et al [13] presented the results of a phase I/II study in 10 patients with early-stage MF who were treated topically with MTX-laurocapram. The gel formulation of the product was applied to the total body surface at daily doses of 12.5 or 25 g/m 2 , excluding the genital, perianal areas, nipples, face and skin under the breasts, on an every-other-day basis for 24 consecutive weeks.…”

Section: Methotrexatementioning

confidence: 99%

New and Experimental Skin-Directed Therapies for Cutaneous Lymphomas

Farkas

Kemény

French

et al. 2009

Skin Pharmacol Physiol

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Primary cutaneous lymphomas (CLs) originate in the skin and should be differentiated from secondary skin infiltrates, which are manifestations of lymphomas of nodal or extranodal origin. These rare diseases include various lymphoproliferative disorders: cutaneous T-cell lymphomas, cutaneous Bcell lymphomas and some rare subtypes. As definitive cure is often not possible, it is important to control the disease and alleviate symptoms. Patients with early-stage disease limited to the skin usually require skin-directed therapies using topical agents including corticosteroids, chemotherapeutic drugs, bexarotene gel, electron beam therapy and phototherapy. Each of these are effective; however, all have some disadvantages and are associated with significant adverse events. In the field of skin-directed therapies there are interesting developments using antineoplastic compounds, the retinoid tazarotene, imiquimod, gene therapy products (adenovirus vector expressing gamma-interferon), the monoclonal anti-CD20 antibody rituximab, photodynamic therapy and 308-nm excimer laser to mention a few. This review highlights some of the promising new and experimental local therapies for primary CLs and focuses on their efficacy and side effects.

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“…After every-other-day application for 24 weeks, 7 out of 9 subjects showed "slight to moderate improvement" with statistically significant reductions in induration and pruritus without any significant toxicity. 41 There are also studies using MTX in combination with other therapies for MF/SS. The largest involves 158 subjects with stage IIB to IVA MF/SS treated with MTX (10 mg/m 2 twice a week) plus IFN-a-2a (9 MU 3 times a week) for 6 months.…”

Section: Wood and Wumentioning

confidence: 99%

Methotrexate and Pralatrexate

Wood

2015

Dermatologic Clinics

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This article reviews methotrexate and the more potent, related compound, pralatrexate, for the treatment of cutaneous T-cell lymphomas, including mycosis fungoides, Sézary syndrome, and CD30+ lymphoproliferative disorders. Although these folate antagonists are traditionally viewed as antiproliferative cell cycle inhibitors, it is recognized that they inhibit DNA methylation, providing a rationale for their use as epigenetic regulators and cell proliferation inhibitors. The underlying mechanisms are outlined, key supporting data presented, followed by brief mention of recent mathematical modeling supporting the general superiority of combination therapy. Several novel examples involving folate antagonists are proposed.

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Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides

Abstract: Objectives: To assess the safety and tolerability of a topical gel formulation combining methotrexate and laurocapram and to obtain preliminary information on the therapeutic potential of methotrexate-laurocapram in patients with early-stage mycosis fungoides (stage IA or IB).

Cited by 24 publications

References 21 publications

Practical Management of CD30+ Lymphoproliferative Disorders

Practical Management of CD30+ Lymphoproliferative Disorders

New and Experimental Skin-Directed Therapies for Cutaneous Lymphomas

Methotrexate and Pralatrexate

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