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CTCL Directed Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03116659
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : August 13, 2019
Information provided by (Responsible Party):
Ali Dana, 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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Cutaneous Drug: Doxycycline Drug: Imiquimod Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CTCL Directed Therapy
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

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

Primary Outcome Measures :
  1. Pilot assessment of response. [ Time Frame: 1 year ]
    Pilot assessment of response assessed by decreased size or surface change of the 5 lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03116659

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Contact: Ali Dana, MD 718-584-9000 ext 5289

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United States, New York
James J Peters Bronx Veterans Affairs Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Ali Dana, MD/PhD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
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Principal Investigator: Ali Dana, MD James J. Peters VAMC
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Responsible Party: Ali Dana, Dermatologist, James J. Peters Veterans Affairs Medical Center Identifier: NCT03116659    
Other Study ID Numbers: DAN-15-028
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers