Health TrialsbyHealthPanel

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

ConditionMycosis Fungoides
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Imiquimod

    Drug

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

  • Radiation Therapy

    Radiation

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Topical IMQ and localized RTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
12 weeks

Secondary outcomes

1

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).

Time frame
12 weeks
2

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).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
Apply now