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

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ClinicalTrials.gov Identifier: NCT02301494
Recruitment Status : Not yet recruiting
First Posted : November 26, 2014
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
Valeant Pharmaceuticals International, Inc.
Rochester Skin Lymphoma Medical Group, PLLC
Information provided by (Responsible Party):
Brian Poligone, MD, PhD, Rochester General Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Drug: 3.75% Imiquimod Cream Drug: 0.1% Fluocinonide Cream Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


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 Name: 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 Name: Zyclara 3.75%



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301494


Contacts
Contact: Carolina V Alexander-Savino, B.S., CCRC 585-489-2883 cva3864@gmail.com

Sponsors and Collaborators
Rochester General Hospital
Valeant Pharmaceuticals International, Inc.
Rochester Skin Lymphoma Medical Group, PLLC
Investigators
Principal Investigator: Brian Poligone, M.D. Ph.D. Rochester General Hospital

Responsible Party: Brian Poligone, MD, PhD, Scientist II, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT02301494     History of Changes
Other Study ID Numbers: 48861
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Poligone, MD, PhD, Rochester General Hospital:
CTCL
Mycosis Fungoides
Cutaneous T-cell Lymphoma
MF
topical therapy
early stage

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Imiquimod
Fluocinonide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents