Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNorthwestern University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Imiquimod
  • Radiation Therapy

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators