CTCL Directed Therapy

Early Phase 1

• Conditions: Lymphoma, T-Cell, Cutaneous
• Interventions: Drug: Doxycycline; Drug: Imiquimod

• Registration Number: NCT03116659
• Lead Sponsor: James J. Peters Veterans Affairs Medical Center

Brief Summary

Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL is made by several years. Early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis.

Inflammation secondary to bacterial infection is thought to contribute to the T-cell proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in CTCL patients. There has been limited studies with the use of antibiotics as direct treatment for this cancer.

Host immunity is important in decreasing cancer development and progression. Imiquimod is a molecule that stimulates host immunity to reduce the progression of CTCL. There is strong evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN) guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it unlikely to be registered specifically for CTCL, despite its efficacy.

Additionally, imiquimod is considered a first line treatment according to National Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.

There are currently no studies that have been published that address treating CTCL patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat patient with 14days of antibiotics and 30 days of Imiquimod there will be significant reduction in skin lesions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-17
• Study Start: 2018-02-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Patients age 30 - 89 years old
• Stages I to II CTCL patients
• Normal renal function, Cr ≤ 1.5

Exclusion Criteria

• Aggressively progressing CTCL
• Active infection and/or concurrent malignancy
• Poor renal function (Cr > 1.5)
• Pregnancy (HCG serum +)
• History of bone marrow suppression, MDS, anemia (Hemoglobin < 8), thrombocytopenia (< 50,000) or neutropenia (ANC < 1500)
• CHF, MI within last 6 months
• Endocarditis
• Allergies to Imiquimod or doxycycline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Imiquimod	Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days
Single Arm	Doxycycline	Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days

Primary Outcome Measures

Name	Time	Method
Pilot assessment of response.	1 year	Pilot assessment of response assessed by decreased size or surface change of the 5 lesions

Trial Locations

Locations (1)

James J Peters Bronx Veterans Affairs Medical Center; 🇺🇸 Bronx, New York, United States