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临床试验/NCT03116659
NCT03116659Unknown早期 1 期

CTCL Directed Therapy

James J. Peters Veterans Affairs Medical Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
8
试验地点
1
主要终点
Pilot assessment of response.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 30 - 89 years old
  • Stages I to II CTCL patients
  • Normal renal function, Cr ≤ 1.5

排除标准

  • 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

研究组 & 干预措施

Single Arm

Experimental

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

干预措施: Doxycycline (Drug)

Single Arm

Experimental

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

干预措施: Imiquimod (Drug)

结局指标

主要结局

Pilot assessment of response.

时间窗: 1 year

Pilot assessment of response assessed by decreased size or surface change of the 5 lesions

次要结局

未报告次要终点

研究者

发起方
James J. Peters Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Ali Dana

Dermatologist

James J. Peters Veterans Affairs Medical Center

研究点 (1)

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