Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course
研究概览
简要总结
RATIONALE: Interferon beta may interfere with the growth of tumor cells.
PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.
详细描述
OBJECTIVES:
- Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta.
- Determine the frequency and degree of apoptosis induction in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma (ocular vs cutaneous).
Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity.
Patients are followed within 3 days after completion of study treatment and then for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course
次要结局
未报告次要终点