Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Dolastatin
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or myelodysplastic syndrome.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of dolastatin 10 in patients with chronic myelogenous leukemia in blast phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes. II. Assess the possible antileukemia effect of this treatment in these patients.
OUTLINE: This is a dose escalation study. Patients receive dolastatin 10 intravenous (IV) bolus once every 3 weeks. Patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients, subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10. If DLT occurs in 2 of 3 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are followed until death.
PROJECTED ACCRUAL: This study will accrue up to 25 patients within 8 months.
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
- 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
MTD Group
干预措施: Dolastatin 10 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Dolastatin
时间窗: Assessed with each 3 week cycle
Maximum tolerated dose defined by dose limiting toxicity of dolastatin.
次要结局
未报告次要终点