Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Launched by NORTHWESTERN UNIVERSITY · Apr 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat mycosis fungoides (MF), a type of skin cancer. The researchers want to see if combining a topical cream called imiquimod with local radiation therapy will be safe and effective for patients. Imiquimod helps stimulate the immune system, which may work alongside radiation therapy to better fight the cancer. The trial is looking for adults aged 18 to 90 who have a confirmed diagnosis of stage IA-IIB mycosis fungoides, have tried at least one other treatment without success, and have active but stable disease for more than six months.

Participants in the trial can expect to apply the imiquimod cream for a week before starting radiation therapy. This is designed to help prepare their immune system to respond better to the radiation treatment. To be eligible, patients should have four or more visible skin lesions from MF, with specific size requirements. However, individuals currently receiving other treatments for MF, pregnant or nursing women, or those with certain medical or social situations that might affect their participation will not be able to join the study. Overall, this trial aims to explore a potentially promising treatment combination for those struggling with this skin condition.

Gender

ALL

Eligibility criteria

• 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 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. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
• • Patients with psychiatric illness/social situations that would limit compliance with study requirements.