Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Northwestern University
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
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who…
Interventions
- DrugImiquimod
5% cream applied topically 5 days/week for 6 weeks
- RadiationRadiation Therapy
2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.
Location
- Northwestern University Department of DermatologyChicago, Illinois