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

Rochester General Hospital

Status: Withdrawn

Conditions: Mycosis Fungoides

Treatments: Drug: 0.1% Fluocinonide Cream; Drug: 3.75% Imiquimod Cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02301494

48861

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Fluocinonide (Vanos) cream 0.1%

Experimental group

Description:

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.

Treatment:

Drug: 0.1% Fluocinonide Cream

3.75% Imiquimod (Zyclara) Cream

Experimental group

Description:

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.

Treatment:

Drug: 3.75% Imiquimod Cream