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

Mycosis Fungoides Clinical Trial

— CTCL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02301494
• Other study ID #: 48861
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: April 2023

Study information

• Verified date: April 2021
• Source: Rochester General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Rochester General Hospital	Bausch Health Americas, Inc., Rochester Skin Lymphoma Medical Group, PLLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response Rate 24 and 52 weeks after baseline	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
Secondary	Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events)	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
Secondary	Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies)	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)