Clinical trial NCT03116659: CTCL Directed Therapy
Official title: CTCL Directed Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lymphoma, T-Cell, Cutaneous
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2017-04-17
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pilot assessment of response.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J Peters Bronx Veterans Affairs Medical Center
state: New York
Study officials:
affiliation: James J. Peters VAMC
name: Ali Dana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Guzzo CA, Kojadinovic A, Vinnakota RR, Geskin LJ, Newman JC, Langhoff E, Park YA, Bates SE, Dana AN. Antibiotics and Imiquimod for Cutaneous T-Cell Lymphoma in Veterans: A Patient Population with Agent Orange Exposure. Oncologist. 2021 Sep;26(9):727-e1488. doi: 10.1002/onco.13785. Epub 2021 May 14.