CTCL Directed Therapy

James J. Peters Veterans Affairs Medical Center

Status and phase

Unknown

Early Phase 1

Conditions

Lymphoma, T-Cell, Cutaneous

Treatments

Drug: Imiquimod

Drug: Doxycycline

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03116659

DAN-15-028

Details and patient eligibility

About

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.

Enrollment

8 estimated patients

Sex

All

Ages

30 to 89 years old

Volunteers

No Healthy Volunteers

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