CTCL Directed Therapy
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|ClinicalTrials.gov Identifier: NCT03116659|
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : August 13, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Single Arm
Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days
Doxycycline 100 mg PO BID x 14 days
up to 2 packs 3/ week x 28 days
- Pilot assessment of response. [ Time Frame: 1 year ]Pilot assessment of response assessed by decreased size or surface change of the 5 lesions
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 ClinicalTrials.gov identifier (NCT number): NCT03116659
|Contact: Ali Dana, MD||718-584-9000 ext 5289||Ali.Dana@VA.gov|
|United States, New York|
|James J Peters Bronx Veterans Affairs Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Ali Dana, MD/PhD|
|Principal Investigator:||Ali Dana, MD||James J. Peters VAMC|