Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 187
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide.
- Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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