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Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

Primary Purpose

Mycosis Fungoides of Skin (Diagnosis), Cutaneous T-cell Lymphoma, Non Hodgkin Lymphoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Med-Jet Injector
Triamcinolone Acetonide
Bexarotene 1% Top Gel
Nitrogen Mustard
Conventional syringe
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mycosis Fungoides of Skin (Diagnosis)

Eligibility Criteria

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

Inclusion Criteria:

  1. > 18 years of age

  2. Diagnosed with primary cutaneous lymphoma defined by either:

    • A board-certified dermatologist, OR
    • Dermatology Nurse Practitioner, OR
    • Skin punch biopsy

  3. The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either:

    • Symmetrically located on contralateral body site OR
    • Within the same body site but separated by ≥ 1 cm
    • Both plaques must be similar in size as much as possible
  4. Able to give informed consent under IRB approval procedures

Exclusion Criteria:

  1. Known allergy or hypersensitivity to triamcinolone acetonide
  2. Known allergy to topical bexarotene or topical nitrogen mustard
  3. Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
  4. Inability to provide informed consent
  5. Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
  6. Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
  7. Use of radiation therapy to target lesions within 1 week prior to baseline visit

Sites / Locations

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cutaneous T-cell lymphomas (CTCL) Participants

Cutaneous B-cell lymphomas (CBCL) Participants

Arm Description

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

The first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

Outcomes

Primary Outcome Measures

Pain measurement between the Med-Jet and standard of care treatment.
The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.

Secondary Outcome Measures

Participants Preference
Number of participants that prefer traditional treatment versus MedJet.
Tolerability of Pruritus
Tolerability will be measured using Pruritus score assessment in the Medjet and topical therapy cohorts using a visual standard analog itching scale 0 (no itch) to 10 (worst itch imaginable) with the affected plaques at each indicated visit.
Quality of life due to skin conditions
The quality of life assessment will be done using the Dermatology Life Quality Index survey (DLQI) which will include a series of topics related to the skin condition including symptoms, feelings, effects on daily life, employment or schooling, personal relationships, and treatment. Each of the ten (10) questions are scored from 0 to 3, giving a score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Resulting scores are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
CAILS assessment of clinical efficacy
Composite Assessment of Index Lesion Severity (CAILS) is an assessment of individual lesions by the investigator of disease severity at the time of evaluation which can be used to monitor and compare lesions over time. CAILS is a 5-criterion scale ranging from 0 (no evidence) to 8 (severe), incorporating an assessment of the size of the lesion and severity of erythema, scaling, plaque elevation, and hypo- or hyperpigmentation. When making the assessment of severity, the Investigator will score the area with most clearance (ie, have scores of 0) within the treated plaque.

Full Information

First Posted
October 12, 2021
Last Updated
October 2, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05106192
Brief Title
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Official Title
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.
Detailed Description
Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body. The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides of Skin (Diagnosis), Cutaneous T-cell Lymphoma, Non Hodgkin Lymphoma, Lymphomatoid Papulosis, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Follicular

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cutaneous T-cell lymphomas (CTCL) Participants
Arm Type
Experimental
Arm Description
The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.
Arm Title
Cutaneous B-cell lymphomas (CBCL) Participants
Arm Type
Experimental
Arm Description
The first plaque will be treated using standard of care intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas). The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.
Intervention Type
Device
Intervention Name(s)
Med-Jet Injector
Intervention Description
The Med-Jet injector is a needle-free injection system that consists of a hand-held firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, and disposable splash guard. The Med-Jet injector is designed to deliver drugs or biologics into the intradermal, subcutaneous, or intramuscular tissues, by means of a narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers the fluid to the target tissue
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
The target lesion will be wiped with alcohol and injected with 10mg/ml of TAC directed towards the dermis to create a blanching wheal that is 1 cubic centimeter (total of 0.20 ml of injected fluid).
Intervention Type
Drug
Intervention Name(s)
Bexarotene 1% Top Gel
Intervention Description
Bexarotene can be applied up to four times daily according to patient tolerance directly to lesions. The gel is 1% bexarotene concentration.
Intervention Type
Drug
Intervention Name(s)
Nitrogen Mustard
Intervention Description
Nitrogen mustard is applied once daily as patient tolerates. It is sold in a concentration of 0.016% gel.
Intervention Type
Device
Intervention Name(s)
Conventional syringe
Intervention Description
A standard sterile disposable 1 ml syringe and 30-gauge needle will be used to inject TAC.
Primary Outcome Measure Information:
Title
Pain measurement between the Med-Jet and standard of care treatment.
Description
The pain of injections with Medjet vs conventional topical therapies of bexarotene or nitrogen mustard will be measured using a visual standard analog pain scale 0 (no distress) to 10 (unbearable distress) immediately after each injection.
Time Frame
1.5 Hour after the treatment
Secondary Outcome Measure Information:
Title
Participants Preference
Description
Number of participants that prefer traditional treatment versus MedJet.
Time Frame
3 Months
Title
Tolerability of Pruritus
Description
Tolerability will be measured using Pruritus score assessment in the Medjet and topical therapy cohorts using a visual standard analog itching scale 0 (no itch) to 10 (worst itch imaginable) with the affected plaques at each indicated visit.
Time Frame
At Baseline, 1 month, 2 months, and 3 months
Title
Quality of life due to skin conditions
Description
The quality of life assessment will be done using the Dermatology Life Quality Index survey (DLQI) which will include a series of topics related to the skin condition including symptoms, feelings, effects on daily life, employment or schooling, personal relationships, and treatment. Each of the ten (10) questions are scored from 0 to 3, giving a score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Resulting scores are as follows: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.
Time Frame
3 Months
Title
CAILS assessment of clinical efficacy
Description
Composite Assessment of Index Lesion Severity (CAILS) is an assessment of individual lesions by the investigator of disease severity at the time of evaluation which can be used to monitor and compare lesions over time. CAILS is a 5-criterion scale ranging from 0 (no evidence) to 8 (severe), incorporating an assessment of the size of the lesion and severity of erythema, scaling, plaque elevation, and hypo- or hyperpigmentation. When making the assessment of severity, the Investigator will score the area with most clearance (ie, have scores of 0) within the treated plaque.
Time Frame
At Baseline, 1 month, 2 months, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years of age Diagnosed with primary cutaneous lymphoma defined by either: A board-certified dermatologist, OR Dermatology Nurse Practitioner, OR Skin punch biopsy The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either: Symmetrically located on contralateral body site OR Within the same body site but separated by ≥ 1 cm Both plaques must be similar in size as much as possible Able to give informed consent under IRB approval procedures Exclusion Criteria: Known allergy or hypersensitivity to triamcinolone acetonide Known allergy to topical bexarotene or topical nitrogen mustard Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. Inability to provide informed consent Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome Use of topical corticosteroids to target lesions within 1 week prior to baseline visit Use of radiation therapy to target lesions within 1 week prior to baseline visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Johnson, MD
Phone
216-286-7369
Email
amy.johnson@uhhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Cooper, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
It will be immediately available upon request at completion of study.

Learn more about this trial

Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

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