Clinical trial NCT02301494: Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mycosis Fungoides
Keywords: CTCL
Mycosis Fungoides
Cutaneous T-cell Lymphoma
MF
topical therapy
early stage
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
name: Rochester Skin Lymphoma Medical Group, PLLC
First posted: 2014-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Response Rate between baseline and week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Response Rate 24 and 52 weeks after baseline
timeFrame: Baseline to up to one year
measure: Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)
timeFrame: From Randomization to up to 30 days after end of treatment
measure: Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies)
timeFrame: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16)
Other outcomes:
Locations:
Study officials:
affiliation: Rochester General Hospital
name: Brian Poligone, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.