NCT00758797终止1 期
In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
研究概览
简要总结
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
详细描述
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.
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
- •Age 18 and older
- •Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
- •Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment):
- •Platelet count > 40,000 per mm3 Absolute Neutrophil Count (ANC) > 1,500 per mm3
排除标准
- •Life expectancy, in the opinion of the investigator of less than 4 months
- •Known allergy to any drugs used in treatment
- •Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment
- •Chemotherapy/immunotherapy within 4 weeks of initiation
- •Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation
- •Radiation therapy at the treatment site within 4 weeks of initiation
- •Uncontrolled brain metastases
- •History of cutaneous photosensitization or photodermatoses
- •Non-treated, active cancers other than melanoma and non-melanoma skin cancers.
- •Active infectious disease requiring antibiotic therapy
- •Unstable medical illness
- •Past or present major psychiatric illness
- •Pregnant or lactating women
- •End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance <50cc/min
- •Acute hepatitis (any cause)
研究组 & 干预措施
1
Experimental
DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
干预措施: Photoimmunotherapy (Other)
结局指标
主要结局
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
时间窗: 24 weeks
次要结局
- Assess time to disease progression(24 weeks to years)
- Quantify overall survival in this study population(years)
- Evaluate tumor response by measuring clinically apparent tumors throughout study.(24 weeks)
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University
研究点 (1)
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