Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
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.
• 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 minimum combined 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 written informed consent document.