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

April 23, 2021 updated by: Brian Poligone, MD, PhD, Rochester General Hospital

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Vanos
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.
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.
Other Names:
  • Zyclara 3.75%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to up to one year
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.
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)
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.
Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Collaborators

Bausch Health Americas, Inc.
Rochester Skin Lymphoma Medical Group, PLLC

Investigators

  • Principal Investigator: Brian Poligone, M.D. Ph.D., Rochester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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