← Back to Search

Topical IMQ and localized RT 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Microbiome alterations before and after treatment

Tumor-associated and serum immune alterations before and after 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

~2260

Radiation Therapy

2017

Completed Phase 3

~7250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

917,062 Total Patients Enrolled

9 Trials studying Mycosis Fungoides

170 Patients Enrolled for Mycosis Fungoides

Alan ZhouPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial inclusive of individuals younger than 70 years old?

"The criteria for participant inclusion in this research trial mandates an age of at least 18 years and a maximum threshold of 90 years."

Answered by AI

Which individuals are eligible to partake in this experimental study?

"Individuals aged between 18 and up to 90 years old diagnosed with mycosis fungoides are eligible for inclusion in this study, which has a capacity of enrolling 25 participants."

Answered by AI

Are there any ongoing efforts to enroll participants for this research study at the moment?

"Indeed, details on clinicaltrials.gov reveal that this medical investigation is presently seeking suitable participants. The trial was initially listed on July 24th, 2023, with the most recent update recorded on March 8th, 2024. Enrollment aims to include a total of 25 patients at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Xiaolong (Alan) Zhou 2023. "Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05838599.

All > Mycosis Fungoides