Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Last updated: March 8, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Mycosis Fungoides

Treatment

Radiation Therapy

Imiquimod

Clinical Study ID

NCT05838599
AZ10312022
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 minimumcombined surface area of >50cm2.
  • POCBP must have a negative pregnancy test prior to registration on study.
  • Patients must have the ability to understand and the willingness to sign a writteninformed consent document.

Exclusion

Exclusion Criteria:

  • Patients who are on current systemic or topical CTCL therapy, unless stable on thetreatment 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 studybecause IMQ is an agent with potential for teratogenic or abortifacient effects.Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the gestational parent with IMQ, breastfeeding should bediscontinued if the parent is treated with IMQ.
  • Patients with psychiatric illness/social situations that would limit compliance withstudy requirements.

Study Design

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Radiation Therapy
Phase: 1
Study Start date:
July 24, 2023
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • Northwestern University Department of Dermatology

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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