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Trial Title:
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
NCT ID:
NCT05838599
Condition:
Mycosis Fungoides
Conditions: Official terms:
Mycoses
Mycosis Fungoides
Imiquimod
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Imiquimod
Description:
5% cream applied topically 5 days/week for 6 weeks
Arm group label:
Topical IMQ and localized RT
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2
days.
Arm group label:
Topical IMQ and localized RT
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University Department of Dermatology
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dermatology CTU
Start date:
July 24, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05838599
