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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
5% cream applied topically 5 days/week for 6 weeks
2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.
Northwestern University Department of Dermatology
Chicago, Illinois, United States
RECRUITINGEfficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.
Time frame: 8 weeks
Incidence of treatment-emergent adverse events (safety and tolerability) of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.
Adverse event occurrence during study.
Time frame: 12 weeks
Microbiome alterations before and after treatment
To measure alterations in lesional (tumor-associated) skin, nasal, and gut microbiomes before and after combination RT/imiquimod treatment and associate these differences in microbiomes with clinical response (and any toxicity). Differences in microbiome bacterial species will be measured by alpha and beta diversity metrics. Alpha diversity quantifies within sample diversity. Beta diversity compares between sample diversity (before and after treatment).
Time frame: 12 weeks
Tumor-associated and serum immune alterations before and after treatment
To correlate quantitative changes in tumor-associated and serum immune response profiles with clinical response to RT/imiquimod treatment (and any toxicity).
Time frame: 12 weeks
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