An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases.
排除标准
- •Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
- •Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted)
- •Participants who are receiving any other investigational agents during the proposed treatment cycle.
研究组 & 干预措施
Open Label
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
干预措施: Verteporfin (Drug)
Open Label
Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin
干预措施: Continuous Low-Irradiance Photodynamic Therapy (CLIPT) (Device)
结局指标
主要结局
Objective Response Rate
时间窗: Day 23
To evaluate the objective response rate (ORR=CR+PR) at Day 23 (3 weeks) after the initial treatment. The objective response rate is defined as the rate of complete response (CR) plus the rate of partial response (PR).
次要结局
未报告次要终点