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RECRUITING
NCT05838599
EARLY_PHASE1

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2023-07-24

Completion Date

2027-12-01

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

Imiquimod

5% cream applied topically 5 days/week for 6 weeks

RADIATION

Radiation Therapy

2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.

Locations (1)

Northwestern University Department of Dermatology

Chicago, Illinois, United States