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Imiquimod + Radiation Therapy for Mycosis Fungoides

Phase < 1

Recruiting

Led By Alan Zhou

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination treatment of radiation therapy and a topical cream called imiquimod for patients with a type of skin cancer called mycosis fungoides. Imiquimod helps

Who is the study for?

This trial is for adults aged 18-90 with confirmed stage IA-IIB mycosis fungoides, a type of skin lymphoma. They should have tried at least one standard treatment without success and have stable disease for over six months. Participants need multiple distinct lesions and must understand and consent to the study.

What is being tested?

The trial tests combining a cream called Imiquimod with local radiotherapy on skin lesions caused by mycosis fungoides. The idea is that the cream boosts the body's immune response which may help make the radiation treatment more effective against this skin cancer.

What are the potential side effects?

Imiquimod can cause redness, swelling, itching or burning at the application site. Radiotherapy might lead to localized skin irritation, fatigue or changes in skin color.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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.

Secondary study objectives

Microbiome alterations before and after treatment

Tumor-associated and serum immune alterations before and after treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Topical IMQ and localized RTExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imiquimod

2005

Completed Phase 4

~2010

Radiation Therapy

2017

Completed Phase 3

~7250