Back to resultsCombining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Primary Purpose
Mycosis Fungoides
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Imiquimod
Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mycosis Fungoides
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topical IMQ and localized RT
Arm Description
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.
Outcomes
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.
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) 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.
Adverse event occurrence during study.
Secondary Outcome Measures
Microbiome alterations before and after treatment
To measure alterations in lesional (tumor-associated) skin, nasal, and gut microbiomes before and after combination RT/imiquimod treatment and associate these differences in microbiomes with clinical response (and any toxicity). Differences in microbiome bacterial species will be measured by alpha and beta diversity metrics. Alpha diversity quantifies within sample diversity. Beta diversity compares between sample diversity (before and after treatment).
Tumor-associated and serum immune alterations before and after treatment
To correlate quantitative changes in tumor-associated and serum immune response profiles with clinical response to RT/imiquimod treatment (and any toxicity).
Full Information
NCT ID
NCT05838599
First Posted
February 6, 2023
Last Updated
April 29, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05838599
Brief Title
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Official Title
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical IMQ and localized RT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
5% cream applied topically 5 days/week for 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
2 fractions of 4 Gys (total of 8 Gys) starting 1 week after Imiquimoid course over 2 days.
Primary Outcome Measure Information:
Title
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
Description
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.
Time Frame
8 weeks
Title
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.
Description
Adverse event occurrence during study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Microbiome alterations before and after treatment
Description
To measure alterations in lesional (tumor-associated) skin, nasal, and gut microbiomes before and after combination RT/imiquimod treatment and associate these differences in microbiomes with clinical response (and any toxicity). Differences in microbiome bacterial species will be measured by alpha and beta diversity metrics. Alpha diversity quantifies within sample diversity. Beta diversity compares between sample diversity (before and after treatment).
Time Frame
12 weeks
Title
Tumor-associated and serum immune alterations before and after treatment
Description
To correlate quantitative changes in tumor-associated and serum immune response profiles with clinical response to RT/imiquimod treatment (and any toxicity).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dermatology Clinical Trials Unit
Phone
312-503-5944
Email
NUderm-research@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Zhou
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
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