CTCL Directed Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma, T-Cell, Cutaneous
• Intervention / Treatment: Drug: Doxycycline; Drug: Imiquimod

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10468
      • Recruiting
      • James J Peters Bronx Veterans Affairs Medical Center
      • Contact: Ali Dana, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days	Drug: Doxycycline; Doxycycline 100 mg PO BID x 14 days; Drug: Imiquimod; up to 2 packs 3/ week x 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot assessment of response.	Pilot assessment of response assessed by decreased size or surface change of the 5 lesions	1 year

Collaborators and Investigators

• Sponsor: James J. Peters Veterans Affairs Medical Center
• Investigators: Principal Investigator: Ali Dana, MD, James J. Peters VAMC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunologic Factors; Anti-Bacterial Agents; Adjuvants, Immunologic; Antiprotozoal Agents; Antiparasitic Agents; Interferon Inducers; Antimalarials; Imiquimod; Doxycycline
• Other Study ID Numbers: DAN-15-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes