Actively Recruiting
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Led by Northwestern University · Updated on 2026-05-01
25
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment using topical imiquimod cream and local radiotherapy for patients with mycosis fungoides (MF), the most common type of cutaneous T cell lymphoma. This trial focuses on patients with conventional CD4+ MF who have active but stable disease and have previously not responded to at least one standard therapy. The study aims to assess the safety and effectiveness of this combined approach in treating MF skin lesions. Participants will apply 5% imiquimod cream to selected lesions five days a week for six weeks. One week after starting imiquimod, they will receive radiation therapy to the same lesions, delivered in two doses of 4 Gy each over two days. This schedule is designed so that imiquimod primes the immune system before radiation is given, potentially enhancing the anti-tumor response. During the study, patients will be monitored for treatment effects and safety through assessments at 8 and 12 weeks, including measuring skin lesion severity using the modified Severity Weighted Assessment Tool (mSWAT). Researchers will also analyze changes in the microbiome and immune markers in tumors and blood. The study participation lasts through initial treatment and follow-up, with careful observation for any side effects or responses to the therapy.
CONDITIONS
Brief Title
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Patients 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.
You will not qualify if you...
- Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for >6 months.
- Patients who have received antibiotic therapy within 4 weeks of study enrollment.
- Patients who are pregnant or nursing.
- Patients with psychiatric illness or social situations that would limit compliance with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants apply 5% imiquimod cream topically 5 days per week for 6 weeks. One week into the imiquimod treatment, participants receive local radiotherapy in 2 fractions over 2 days targeting the same lesions.
1 baseline visit and 2 radiation visits during Week 2
Duration - 6 weeks
Participants are monitored for efficacy and safety outcomes including adverse events, microbiome, and immune system changes after treatment ends.
Approximately 2 visits during the 6-week follow-up
Trial Site Locations
Total: 1 location
1
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
D
Dermatology Clinical Trials Unit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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