Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Northwestern University Department of Dermatology
RECRUITING
Chicago
Contact Information
Primary
Dermatology Clinical Trials Unit
NUderm-research@northwestern.edu
312-503-5944
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 25
Treatments
Experimental: Topical IMQ and localized RT
After the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size \>50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions.
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov