Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
研究概览
简要总结
Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (MF) and presents as cutaneous patches, plaques, and tumors. Radiation therapy (RT) is a frequently pursued management option for CTCL, especially in patients with more advanced skin disease. Imiquimod stimulates a Th1 lymphocyte response with increased IL-2 and IFN-α, but also induces IFN-α, TNF-α, IL-1α, IL-6, and IL-8, thereby bridging both innate and adaptive immunity. Dosing of both radiotherapy (RT) and imiquimod are based on standard-of-care doses/frequencies for CTCL. The reason imiquimod topical is given for a week before giving RT is to prime innate immune activity for when RT is delivered. It is believed that this serves as an adjuvant for the CD8+ antitumor response generated by RT. The primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have confirmed stage IA-IIB mycosis fungoides.
- •Patients must be 18-90 years of age.
- •Patients must have failed at least one standard therapy for MF.
- •Patients must have active, but stable disease for >6 months.
- •Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of >50cm
- •POCBP must have a negative pregnancy test prior to registration on study.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for >6 months.
- •Patients who have received antibiotic therapy within 4 weeks of study enrollment.
- •Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Topical IMQ and localized RT
After the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size >50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions.
干预措施: Radiation Therapy (Radiation)
Topical IMQ and localized RT
After the initial study visit, patients will immediately begin use of imiquimod cream at designated lesions (those with combined size >50cm2) nightly for 5 consecutive days a week over 6 weeks. One week into the imiquimod treatment course, radiation therapy will be administered at Northwestern Medicine by radiation oncologists familiar with MF in 2 fractions of 4 Gy (total 8 Gy) over 2 days to the same designated lesions.
干预措施: Imiquimod (Drug)
结局指标
主要结局
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
时间窗: 8 weeks
The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.
Incidence of treatment-emergent adverse events (safety and tolerability) of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.
时间窗: 12 weeks
Adverse event occurrence during study.
次要结局
- Microbiome alterations before and after treatment(12 weeks)
- Tumor-associated and serum immune alterations before and after treatment(12 weeks)
研究者
Xiaolong (Alan) Zhou
Principal Investigator
Northwestern University