Combining a topical treatment with radiation for skin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the combination of topical imiquimod and local radiotherapy for treating mycosis fungoides, a common form of cutaneous T cell lymphoma. Patients will receive imiquimod for one week to enhance their immune response before undergoing radiation therapy. The goal is to evaluate the safety and efficacy of this combined approach in patients who have not responded to standard treatments. The study focuses on patients with specific stages of the disease and multiple lesions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northwestern University Department of Dermatology
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Alan Zhou — Northwestern University
• Study coordinator: Dermatology Clinical Trials Unit
• Email: NUderm-research@northwestern.edu
• Phone: 312-503-5944

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.