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

Overview

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).

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2022

Detailed Description

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.

Interventions

• Drug: 3.75% Imiquimod Cream
  • 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.
• Drug: 0.1% Fluocinonide Cream
  • 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.

Arms, Groups and Cohorts

• Experimental: Fluocinonide (Vanos) cream 0.1%
  • 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.
• Experimental: 3.75% Imiquimod (Zyclara) Cream
  • 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.

Clinical Trial Outcome Measures

Primary Measures

• Response Rate between baseline and week 16
  • Time Frame: 16 weeks
  • Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Male and female subjects aged ≥18 years. 2. Willing and able to give informed consent 3. 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. 4. Subjects must have at least one target lesion 5. Subjects will be able to comply with the study instructions, apply the study medication as directed and attend all visits. 6. 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. 7. Patients must be otherwise healthy with an ECOG Performance status of 0 or 1. 8. 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. 9. 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: 1. Female who is pregnant, nursing an infant, or planning a pregnancy during the study period. 2. 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. 3. Received any investigational drug or taking part in any clinical study within one month prior to this study. 4. Known reaction or allergy to test drug or excipient. 5. Presence of major medical illness or symptoms of a clinically significant illness that may influence the study. 6. 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. 7. Lesions on the genitals, axillae and face will not be selected for study treatment and evaluation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Rochester General Hospital
• Collaborator
  • Bausch Health Americas, Inc.
• Provider of Information About this Clinical Study
  • Principal Investigator: Brian Poligone, MD, PhD, Scientist II – Rochester General Hospital
• Overall Official(s)
  • Brian Poligone, M.D. Ph.D., Principal Investigator, Rochester General Hospital