Mechlorethamine Induced Contact Dermatitis Avoidance Study (MIDAS)

Rochester Skin Lymphoma Medical Group, PLLC

Status and phase: Completed; Phase 2

Conditions: Mycosis Fungoides Variant; Cutaneous T-cell Lymphoma; Granulomatous Slack Skin; Cutaneous T-cell Lymphoma Stage I; Syringotropic Mycosis Fungoides; Mycosis Fungoides; Folliculotropic Mycosis Fungoides; Transformed Mycosis Fungoides

Treatments: Drug: Valchlor 0.016 % Topical Gel; Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03380026

RSLMG-17.10

Details and patient eligibility

About

This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.

Full description

Mechlorethamine hydrochloride, or most commonly known as nitrogen nitrogen mustard, was approved by the FDA in 2013 for the treatment of IA and IB Mycosis Fungoides. The most common side effect of Valchlor is a skin rash, which is routinely ameliorated with the application of topical corticosteroids, such as topical Triamcinolone. The main purpose of this study is to determine the efficacy of Triamcinolone in reducing side effects cause by Valchlor and further understand the nature of this skin rash.

This is a split-face study, meaning that subjects will receive both therapies, but limit use to designated areas. Treatment lasts 4 months with follow ups at 5 and 12 months.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be eligible to receive Valchlor therapy.
• Be at least of 18 years of age and ability to give informed consent
• Have stage IA or IB CTCL
• Subjects with histologic variants of Mycosis Fungoides such as folliculotropic, granulomatous slack skin, syringotropic MF, or large cell transformation ARE eligible.
• A skin biopsy within the last 60 days before start of treatment. In cases with equivocal histological features, the diagnosis may be confirmed with clinicopathologic and/or genetic testing consistent with the National Comprehensive Cancer Network guidelines for Mycosis Fungoides. If sufficient tissue is not available to perform genetic testing, a new biopsy will be performed even if the subject has had a biopsy within 60 days of start of treatment.
• Females of child bearing potential must agree to use two highly effective methods of contraception (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device until 30 days after the last day of drug administration. Perimenopausal women must be amenorrhoeic for at least 12 months to be considered of nonchildbearing potential.
• Males with female partners of child bearing potential must agree to sexual abstinence or use two reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms should be non-hormonal as described above) during the entire treatment period and 30 days after the last dose.
• Must be able to comply with the study instructions, apply the study medication as directed, and attend all visits.
• Willingness to avoid sun exposure and ultraviolet B light in areas to be treated.

Exclusion criteria

• Have been treated with topical mechlorethamine within 6 months in lesions followed during this study.
• Have received any topical therapy directed against MF within 2 weeks of start of treatment in areas intended to be treated in this study.
• Have received any systemic therapy (oral or injectables) within 3 weeks of start of treatment.
• Not have any intercurrent illness or infection that would interfere with study participation
• Known hypersensitivity to mechlorethamine or triamcinolone.
• Breastfeeding, pregnancy, or intention to become pregnant.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Valchlor 0.016% Topical Gel

Experimental group

Description:

0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.

Treatment:

Drug: Valchlor 0.016 % Topical Gel

Valchlor plus Triamcinolone

Active Comparator group

Description:

0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.

Treatment:

Drug: Triamcinolone

Drug: Valchlor 0.016 % Topical Gel