Recruiting
Early Phase 1

CTCL

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT03116659

Conditions

Lymphoma, T-Cell, Cutaneous

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Doxycycline

Imiquimod

Study Details

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.

Conditions

Lymphoma, T-Cell, Cutaneous

Study ID

NCT03116659

Start date

Feb 1, 2018

Status verified date

Aug, 2019

Completion date

Dec 30, 2020

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days

Interventions

Doxycycline

Doxycycline 100 mg PO BID x 14 days

Imiquimod

up to 2 packs 3/ week x 28 days

Primary outcome measure

  • Pilot assessment of response. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

James J Peters Bronx Veterans Affairs Medical Center

Recruiting

Bronx, New York, United States, 10468

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Aug 13, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2019-08-13.