Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

Study Overview
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Brief Summary
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This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

Detailed Description
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The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.

Official Title
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Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma

Conditions
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Mycosis Fungoides

Intervention / Treatment
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* Drug: 3.75% Imiquimod Cream
* Drug: 0.1% Fluocinonide Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged ≥18 years. Willing and able to give informed consent Diagnosis of Mycosis Fungoides In cases with equivocal histological features, the diagnosis may be confirmed through the use of clonal T-cell gamma gene rearrangement, as detected by PCR amplification and primer sets specific for the T-cell receptor gamma chain genes. Subjects must have at least one target lesion Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits. Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate method of contraception (abstinence, condoms, hormonal therapy, barrier methods) during the study. Patients must be otherwise healthy with an ECOG Performance status of 0 or 1. The patient must not have had topical (2 weeks) or systemic therapy (4 weeks), radiotherapy (4 weeks) or phototherapy therapy (4 weeks) for Mycosis Fungoides within the stated number of weeks prior to start of treatment. Eligible patients will be those who topical corticosteroid would be a preferred treatment and include patients newly diagnosed with stage IA, IB, or IIA disease, or those patients currently stable on therapy, in whom topical corticosteroids are being newly added to the regimen (i.e. recurrence or resistant lesions not currently treated with topical corticosteroids) Exclusion Criteria: To be eligible for inclusion in this study the subjects must not meet any of the following criteria: Female who is pregnant, nursing an infant, or planning a pregnancy during the study period. Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug. Received any investigational drug or taking part in any clinical study within one month prior to this study. Known reaction or allergy to test drug or excipient. Presence of major medical illness or symptoms of a clinically significant illness that may influence the study. Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk such as a history of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol. Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluocinonide (Vanos) cream 0.1%<br>Fluocinonide (Vanos) cream 0.1% will be applied as currently approved by the FDA for treatment of corticosteroid responsive disorders of the skin. Treatment will continue for 4 months with a follow up at 6 and 12 months. | Drug: 0.1% Fluocinonide Cream<br>* CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.<br>* Other names: Vanos;|
| Experimental: 3.75% Imiquimod (Zyclara) Cream<br>3.75% Imiquimod (Zyclara) Cream will be used as currently labeled by the FDA for treatment of actinic keratoses. Treatment will continue for 4 months with follow up at 6 and 12 months. | Drug: 3.75% Imiquimod Cream<br>* CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.<br>* Other names: Zyclara 3.75%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate between baseline and week 16 | Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate 24 and 52 weeks after baseline | Patients will be treated for 4 months and response rate assessed at 6 and 24 months after initiation of therapy. | Baseline to up to one year | 
| Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events) | We will record any adverse events that occur during the course of the study. | From Randomization to up to 30 days after end of treatment | 
| Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies) | Using left over tissue from biopsies done at baseline, two weeks after initiation of therapy, and optional one done at week16. We are interested in making our tissue bank. | Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTCL, Mycosis Fungoides, Cutaneous T-cell Lymphoma, MF, topical therapy, early stage