NCT00079404已完成1 期
A Phase I Study of 17-AAG in Relapsed/Refractory Pediatric Patients With Solid Tumors or Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- MTD defined as the maximum dose at which fewer than one-third of patients experience DLT
研究概览
简要总结
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or refractory solid tumors or leukemia. Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the maximum tolerated dose (MTD) and recommended phase II dose of 17-AAG administered as a 60 or 120-minute intravenous infusion on days 1, 4, 8, and 11, of a 21-day course, to children with refractory solid tumors or relapsed leukemia.
II. To define and describe the toxicities of 17-AAG administered on this schedule.
III. To characterize the pharmacokinetics of 17-AAG in children with refractory cancer.
SECONDARY OBJECTIVES:
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
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow
- •Histologic confirmation of intrinsic brain stem tumors not required
- •Relapsed or refractory disease
- •No known curative therapy
- •In patients with CNS tumors, neurologic deficits must be stable for at least the past week
- •Performance status - Karnofsky 50-100% (>10 years of age)
- •Performance status - Lansky 50-100% (≤ 10 years of age)
- •For patients with solid tumors:
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3 (transfusion independent)
- •Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
- •For patients with leukemia:
- •Platelet count ≥ 20,000/mm^3 (may receive platelet transfusions)
- •Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN
- •Albumin ≥ 2 g/dL
- •Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
- •Creatinine based on age as follows:
- •≤ 0.8 mg/dL if ≤ 5 years of age
- •≤ 1.0 mg/dL if > 5 years and ≤ 10 years of age
- •≤ 1.2 mg/dL if > 10 years and ≤ 15 years of age
- •≤ 1.5 mg/dL if > 15 years and ≤ 21 years of age
- •No uncontrolled infection
- •No prior severe allergy to eggs
- •No situation that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered
- •At least 7 days since prior hematopoietic growth factors
- •At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease
- •No concurrent hematopoietic growth factors
- •No concurrent biologic therapy
- •No concurrent immunotherapy
- •At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- •No other concurrent chemotherapy
- •No concurrent steroid therapy
- •At least 2 weeks since prior local palliative radiotherapy (small port)
- •At least 3 months since prior total body irradiation or craniospinal radiotherapy
- •At least 3 months since prior radiotherapy to ≥ 50% of the pelvis
- •At least 6 weeks since prior substantial bone marrow radiotherapy
- •Recovered from prior radiotherapy
- •No concurrent radiotherapy
- •No other concurrent investigational drugs
- •No other concurrent anticancer agents
- •No concurrent phenytoin or phenobarbital
- •No concurrent warfarin
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60-120 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
干预措施: tanespimycin (Drug)
结局指标
主要结局
MTD defined as the maximum dose at which fewer than one-third of patients experience DLT
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
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