Combining a topical treatment with radiation for skin lymphoma
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
This study is testing if using a skin cream along with radiation can help patients with a type of skin lymphoma that hasn't improved with regular treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05838599 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with confirmed stage IA-IIB mycosis fungoides who have failed at least one standard therapy.
Not a fit: Patients currently undergoing systemic or topical CTCL therapy or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with mycosis fungoides who have not responded to previous therapies.
How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with radiotherapy have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.