CTCL Directed Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, T-Cell, Cutaneous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

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

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Doxycycline 100 mg PO BID x 14 days

Imiquimod

Intervention Type DRUG

up to 2 packs 3/ week x 28 days

Interventions

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Doxycycline

Doxycycline 100 mg PO BID x 14 days

Intervention Type DRUG

Imiquimod

up to 2 packs 3/ week x 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No