Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.
详细描述
OBJECTIVES:
- Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
- Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
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 120 Years（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
研究组 & 干预措施
Treatment
IFN weekly
干预措施: recombinant interferon alpha-1b (Biological)
Treatment
IFN weekly
干预措施: IFN (Drug)
结局指标
主要结局
Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course
时间窗: 3 years
次要结局
未报告次要终点