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

NCT02301494 | Withdrawn DMC

• 1 other identifier: 48861
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mycosis Fungoides

Keywords

CTCL; Mycosis Fungoides; Cutaneous T-cell Lymphoma; MF; topical therapy; early stage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response Rate 24 and 52 weeks after baseline

  Baseline to up to one year

• Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)

  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)

  Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)

Study Arms (2)

Fluocinonide (Vanos) cream 0.1%

EXPERIMENTAL

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

3.75% Imiquimod (Zyclara) Cream

EXPERIMENTAL

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

Interventions

3.75% Imiquimod Cream DRUG

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.

Also known as: Zyclara 3.75%

3.75% Imiquimod (Zyclara) Cream

0.1% Fluocinonide Cream DRUG

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.

Also known as: Vanos

Fluocinonide (Vanos) cream 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochester General Hospital: lead
• Bausch Health Americas, Inc.: collaborator
• Rochester Skin Lymphoma Medical Group, PLLC: collaborator

Related Publications (1)

• Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

  PMID: 32632956 DERIVED

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous

Interventions

Fluocinonide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Brian Poligone, M.D. Ph.D.

  Rochester General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist II

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 26, 2014
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share