Actively Recruiting

Early Phase 1
Age: 18Years - 90Years
All Genders
NCT05838599

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Led by Northwestern University · Updated on 2026-05-01

25

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses/frequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.

CONDITIONS

Official Title

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have confirmed stage IA-IIB mycosis fungoides.
  • Patients must be 18-90 years of age.
  • Patients must have failed at least one standard therapy for MF.
  • Patients must have active, but stable disease for >6 months.
  • Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of >50cm2.
  • Patients must have a negative pregnancy test prior to registration on study.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.
Not Eligible

You will not qualify if you...

  • Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for >6 months.
  • Patients who have received antibiotic therapy within 4 weeks of study enrollment.
  • Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University Department of Dermatology

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

D

Dermatology Clinical Trials Unit

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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