Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

NCT05838599 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: AZ10312022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (2)

• Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.

  The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.

  8 weeks

• Incidence of treatment-emergent adverse events (safety and tolerability) of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.

  Adverse event occurrence during study.

  12 weeks

Secondary Outcomes (2)

• Microbiome alterations before and after treatment

  12 weeks

• Tumor-associated and serum immune alterations before and after treatment

  12 weeks

Study Arms (1)

Topical IMQ and localized RT

EXPERIMENTAL

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.

Drug: Imiquimod; Radiation: Radiation Therapy

Interventions

Imiquimod DRUG

5% cream applied topically 5 days/week for 6 weeks

Topical IMQ and localized RT

Radiation Therapy RADIATION

2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.

Topical IMQ and localized RT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

Imiquimod; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Alan Zhou

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dermatology Clinical Trials Unit

CONTACT

312-503-5944; NUderm-research@northwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 1, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)