RecruitingEarly Phase 1NCT05838599

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Sponsor

Northwestern University

Enrollment

25 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Mycosis Fungoides

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study combines imiquimod cream — which activates the immune system — with localized radiation therapy for people with mycosis fungoides, a slow-growing skin lymphoma (a cancer of immune cells in the skin). Researchers want to see if this combination can treat multiple skin lesions more effectively. **You may be eligible if...** - You have confirmed early-to-moderate stage mycosis fungoides (stage IA to IIB) - You are 18 to 90 years old - You have tried at least one standard treatment that did not work - You have 4 or more distinct skin lesions, with at least 2 covering a combined area larger than 50 cm squared - Your disease has been stable but active for more than 6 months **You may NOT be eligible if...** - You are pregnant or could become pregnant without using birth control - You have advanced or rapidly progressing disease - You are unable to apply topical cream or attend radiation sessions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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