A Phase I Trial of Tomudex in Children With Leukemia
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
- MTD based on incidence of DLT graded according to CTC version 2.0
研究概览
简要总结
Phase I trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia.
II. Determine the incidence and severity of other toxic effects of this regimen in these patients.
III. Determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase II studies.
IV. Determine the pharmacokinetics of this regimen in these patients. V. Determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven acute leukemia (M3 marrow) that is refractory to conventional therapy or for which no effective therapy exists
- •No CNS leukemia
- •No solid tumors
- •Performance status: Karnofsky 50-100% OR Lansky at least 50 (for infants)
- •Life expectancy: At least 8 weeks
- •Bilirubin less than 1.5 mg/dL
- •SGPT less than 5 times normal
- •Normal creatinine for age OR GFR at least 70 mL/min
- •No significant systemic illness such as infection
- •No significant third space fluid collection
- •Not pregnant or nursing
- •Recovered from acute toxic effects of prior immunotherapy
- •At least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease
- •At least 10 days since prior biologic therapy
- •At least 1 week since prior growth factors
- •At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered
- •No concurrent steroids
- •Recovered from acute toxic effects of all prior radiotherapy
- •At least 2 weeks since prior local palliative radiotherapy (small port)
- •At least 6 months since prior substantial bone marrow radiation
- •No other concurrent anticancer therapy or investigational agents
- •No concurrent nonsteroidal anti-inflammatory agents
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. Treatment continues in the absence of disease progression and unacceptable toxicity.
干预措施: raltitrexed (Drug)
结局指标
主要结局
MTD based on incidence of DLT graded according to CTC version 2.0
时间窗: Up to 4 weeks
次要结局
未报告次要终点