This phase I/II trial tests the safety and side effects of imiquimod and radiation therapy and how well they work in treating patients with mycosis fungoides. Imiquimod is in a class of medications called immune response modifiers. It also activates immune cells to attack and eliminate cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving imiquimod and radiation therapy may improve local control of mycosis fungoides.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05838599.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern UniversityStatus: Active
Contact: Xiaolong Zhou
Phone: 312-695-0467
PRIMARY OBJECTIVE:
I. To assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) mycosis fungoides (MF).
EXPLORATORY OBJECTIVES:
I. To measure alterations in lesional (tumor-associated) skin, nasal, and gut microbiomes before and after combination radiation therapy (RT)/imiquimod treatment and associate these differences in microbiomes with clinical response (and any toxicity).
II. To correlate quantitative changes in tumor-associated and serum immune response profiles with clinical response to RT/imiquimod treatment (and any toxicity).
OUTLINE:
Patients apply imiquimod topically nightly to the designated lesions for 3-5 days a week over 6 weeks. One week into the imiquimod treatment, patients undergo radiation therapy over 2 days. Patients also undergo skin biopsies, nasal swab, stool swab, and blood sample collection during screening and at week 8.
After completion of study treatment, patients are followed up at 7, 8, and 12 weeks and then every 3 months for 1 year.
Lead OrganizationNorthwestern University
Principal InvestigatorXiaolong Zhou
