Recruiting
Early Phase 1

Imiquimod & Radiotherapy

Sponsor:

Northwestern University

Code:

NCT05838599

Conditions

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Imiquimod

Radiation Therapy

Study Details

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

Study ID

NCT05838599

Start date

Jul 24, 2023

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Topical IMQ and localized RT

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.

Interventions

Imiquimod

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

Radiation Therapy

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

Primary outcome measure

  • Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8. [ Time Frame: 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. [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dermatology Clinical Trials Unit

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

Locations

Northwestern University Department of Dermatology

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Northwestern University

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-01.