NCT05838599

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mycosis Fungoides

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-24
• Primary completion: 2025-08-01
• Completion: 2026-02-01
• First posted: 2023-05-01
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study