Clinical trial NCT03380026: Mechlorethamine Induced Contact Dermatitis Avoidance Study
Official title: Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous T-cell Lymphoma
Cutaneous T-cell Lymphoma Stage I
Mycosis Fungoides
Folliculotropic Mycosis Fungoides
Granulomatous Slack Skin
Syringotropic Mycosis Fungoides
Mycosis Fungoides Variant
Transformed Mycosis Fungoides
Keywords: CTCL
topical mechlorethamine
Valchlor
contact dermatitis
triamcinolone
MF
Cutaneous T-cell Lymphoma
Lead sponsor: Rochester Skin Lymphoma Medical Group, PLLC
Sponsor class: OTHER
Collaborators: name: Rochester General Hospital
First posted: 2017-12-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: open-label, split-face study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
timeFrame: 4 months
Secondary outcomes:
measure: Nature of Contact Dermatitis (Allergic Versus Irritant)
timeFrame: 4 months
Other outcomes:
measure: Severity of Dermatitis
timeFrame: 4 months
measure: Efficacy of Valchlor vs Valchlor Plus Triamcinolone
timeFrame: 4 months
Locations:
city: Fairport
country: United States
facility: Rochester Skin Lymphoma Medical Group, PLLC
state: New York
Study officials:
affiliation: Rochester Skin Lymphoma Medical Group, PLLC
name: Brian Poligone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Alexander-Savino CV, Chung CG, Gilmore ES, Carroll SM, Poligone B. Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides. Dermatol Ther (Heidelb). 2022 Mar;12(3):643-654. doi: 10.1007/s13555-022-00681-6. Epub 2022 Feb 5.