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Mechlorethamine Induced Contact Dermatitis Avoidance Study (MIDAS)

Primary Purpose

Cutaneous T-cell Lymphoma, Cutaneous T-cell Lymphoma Stage I, Mycosis Fungoides

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Triamcinolone

Valchlor 0.016 % Topical Gel

About this trial

This is an interventional supportive care trial for Cutaneous T-cell Lymphoma focused on measuring CTCL, topical mechlorethamine, Valchlor, contact dermatitis, triamcinolone, MF, Cutaneous T-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rochester Skin Lymphoma Medical Group, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Valchlor 0.016% Topical Gel

Valchlor plus Triamcinolone

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as >25 by SCORD.

Secondary Outcome Measures

Nature of Contact Dermatitis (Allergic Versus Irritant)

The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects presenting to the clinic with dermatitis underwent patch testing to determine the presence of allergic vs. Irritant contact dermatitis, and at each case a biopsy sample was taken of the affected area to confirm the diagnosis. Patch testing was assessed by the investigator according to the International Contact Dermatitis Research Group scale, using the following for possible outcomes : ?+ indicates a doubtful reaction, 1+ indicates a weak reaction, 2+ represents a strong reaction, 3+ indicates an extreme reaction, and IR indicates an Irritant reaction. A higher score would indicate a worse outcome. 1-3+ reaction at the 96hr reading was considered positive for allergic contact dermatitis.

Full Information

NCT ID

NCT03380026

First Posted

December 12, 2017

Last Updated

October 27, 2021

Sponsor

Rochester Skin Lymphoma Medical Group, PLLC

Collaborators

Rochester General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03380026

Brief Title

Mechlorethamine Induced Contact Dermatitis Avoidance Study

Acronym

MIDAS

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

December 13, 2017 (Actual)

Primary Completion Date

August 3, 2020 (Actual)

Study Completion Date

December 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rochester Skin Lymphoma Medical Group, PLLC

Collaborators

Rochester General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

open-label, split-face study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valchlor 0.016% Topical Gel

Arm Type

Experimental

Arm Description

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

Arm Title

Valchlor plus Triamcinolone

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Other Intervention Name(s)

triamcinolone acetonide, Triamcinolone 0.1% ointment

Intervention Description

Apply up to three times daily on select lesions.

Intervention Type

Drug

Intervention Name(s)

Valchlor 0.016 % Topical Gel

Other Intervention Name(s)

topical nitrogen mustard, mechlorethamine hydrochloride, mechlorethamine gel

Intervention Description

Apply valchlor nightly on select lesions.

Primary Outcome Measure Information:

Title

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Nature of Contact Dermatitis (Allergic Versus Irritant)

Description

Time Frame

4 months

Other Pre-specified Outcome Measures:

Title

Severity of Dermatitis

Description

Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score "A." The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, "B." Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score "C". The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome. A lower score would be a better outcome.

Time Frame

4 months

Title

Efficacy of Valchlor vs Valchlor Plus Triamcinolone

Description

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is >1.0 will indicate worsening of disease.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Poligone, MD, PhD

Organizational Affiliation

Rochester Skin Lymphoma Medical Group, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rochester Skin Lymphoma Medical Group, PLLC

City

Fairport

State/Province

New York

ZIP/Postal Code

14450

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be embargoed until the study site has fully examined it. Expected embargo would be one year from study completion. Study data that is de-identified will be maintained at the study site. As this field is rapidly changing, if a database is available for safe, public upload at the end of study embargo, it will be uploaded to a national database. Otherwise requests for use of the study data will be accepted at the study site and shared with investigators whose proposed use of data has been approved by an independent institutional review board. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.

IPD Sharing Time Frame

Expected embargo would be one year from study completion. De-identified data will be maintained at the study site for 2 years after the study ends. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.

IPD Sharing Access Criteria

Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.

Citations:

PubMed Identifier

23069814

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.

Results Reference

background

PubMed Identifier

35122614

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.

Results Reference

derived

Links:

URL

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202317lbl.pdf

Description

Valchlor package insert

URL

https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=12961

Description

Triamcinolone acetonide information

Learn more about this trial

Mechlorethamine Induced Contact Dermatitis Avoidance Study

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