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Corticosteroid

Needle-free Triamcinolone Acetonide Injection for Cutaneous Lymphoma

N/A

Waitlist Available

Led By Kevin Cooper, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

> 18 years of age

Must not have

Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome

Use of radiation therapy to target lesions within 1 week prior to baseline visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 1 month, 2 months, and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the MedJet needle-free drug-delivery system to standard care for treating skin lymphomas.

Who is the study for?

Adults diagnosed with primary cutaneous lymphoma by a dermatologist, nurse practitioner, or biopsy can join. They must have similar-sized skin plaques suitable for treatment and be able to consent. Excluded are those allergic to trial drugs, pregnant or breastfeeding women, patients with certain severe lymphomas, or recent users of corticosteroids/radiation on lesions.

What is being tested?

The study is testing the pain levels when using MedJet needle-free system versus conventional syringes for delivering Triamcinolone Acetonide into skin lymphoma plaques. It also looks at how well these methods work compared to standard treatments like Bexarotene gel and Nitrogen Mustard.

What are the potential side effects?

Triamcinolone may cause skin irritation, increased infection risk at injection sites, changes in skin color or texture. Bexarotene could lead to itching or redness where applied. Nitrogen Mustard might result in local blistering and long-term skin discoloration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have skin lymphoma with two large, similar-sized patches on my body.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with erythrodermic mycosis fungoides or Sezary syndrome.

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I have not had radiation therapy targeting lesions within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 1 month, 2 months, and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 1 month, 2 months, and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1 month, 2 months, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain measurement between the Med-Jet and standard of care treatment.

Secondary study objectives

CAILS assessment of clinical efficacy

Participants Preference

Quality of life due to skin conditions

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cutaneous T-cell lymphomas (CTCL) ParticipantsExperimental Treatment4 Interventions

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.

Group II: Cutaneous B-cell lymphomas (CBCL) ParticipantsExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triamcinolone Acetonide

2018

Completed Phase 4

~3730

Nitrogen Mustard

2006

Completed Phase 2

~90