Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

NCT ID: NCT05838599

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2026-02-01

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Imiquimod

Intervention Type: DRUG

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

Radiation Therapy

Intervention Type: RADIATION

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

Interventions

Imiquimod

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

Intervention Type: DRUG

Radiation Therapy

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong (Alan) Zhou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Zhou

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dermatology Clinical Trials Unit

Role: CONTACT

NUderm-research@northwestern.edu

312-503-5944

Facility Contacts

Dermatology CTU

Role: primary

Other Identifiers

AZ10312022

Identifier Type: -

Identifier Source: org_study_id