A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose or the optimal immunologic dose of alefacept in patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.
Secondary
- Determine if antitumor activity of this drug exists in these patients.
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 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
alefacept
Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.
干预措施: Alefacept (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 8 weeks from registration
The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment.\> \> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\> * grade 4 toxicity for neutrophils (\<0.5 x 109/L) or platelets (\<25 x 109/L)\> * any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\> * more than 10 x ULN AST toxicity for more than 14 days\> * any grade 4 infection.\> The number of patients who reported a dose limiting toxicity is reported here.
Maximum Tolerated Dose (MTD)
时间窗: 8 weeks from registration
The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on DLT toxicities encountered during the first 8 weeks of treatment reported in Primary Outcome Measure #1.
次要结局
- Clinical Response(up to 12 cycles (28 days per cycle) of treatment.)