Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.
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
- •Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
- •Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.
排除标准
- •Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
- •Patients with history of metastatic cancer (other than melanoma).
- •Patients not able to provide consent for the study.
- •Patients with clinical or radiographic evidence of extraocular extension of the tumor.
- •Patients with a previous history of an adverse reaction to intravitreal injection.
- •Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
- •Patients with intravitreal silicone oil or gas tamponade.
- •Patients < 18 years of age.
- •Women known to be pregnant.
研究组 & 干预措施
1
AVASTIN
干预措施: AVASTIN (Drug)
结局指标
主要结局
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
时间窗: At conclusion of study, up to 5 days
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease
次要结局
未报告次要终点