CTCL Directed Therapy

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

CTCL Directed Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03116659
• Other study ID #: DAN-15-028
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2019
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: Ali Dana, MD
• Phone: 718-584-9000
• Email: Ali.Dana[@]VA.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Doxycycline
Doxycycline 100 mg PO BID x 14 days
• Imiquimod
up to 2 packs 3/ week x 28 days

Locations

Country	Name	City	State
United States	James J Peters Bronx Veterans Affairs Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot assessment of response.	Pilot assessment of response assessed by decreased size or surface change of the 5 lesions	1 year