NCT00360854Unknown1 期
Phase I Studies of TARCEVA™ (ERLOTINIB HYDROCHLORIDE, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2005年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 试验地点
- 41
- 主要终点
- Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed brain stem glioma.
详细描述
OBJECTIVES:
Primary
- Establish the maximum tolerated dose of single-agent erlotinib hydrochloride in pediatric patients with refractory or relapsed malignant brain tumors and in combination with radiotherapy in pediatric patients with newly diagnosed brain stem glioma.
Secondary
- Determine dose-limiting toxicities of these regimens.
- Define the safety profile of these regimens.
- Characterize the pharmacokinetic behavior of erlotinib hydrochloride in these patients.
- Evaluate the efficacy of these regimens.
- Correlate expression and mutations of epidermal growth factor receptor with treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Histologically or cytologically confirmed malignant brain tumor
- •Refractory to first-line therapy or relapsed after conventional therapy
- •No effective conventional therapy exists
- •Histologically confirmed brain stem glioma
- •Newly diagnosed disease
- •No pilocytic glioma
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2 OR Lansky play scale 50-100%
- •Patients with motor paresis due to disease are eligible
- •Neurological deficits must be stable for ≥ 1 week
- •Life expectancy ≥ 8 weeks
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 8 g/dL
- •AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine < 1.5 times ULN OR creatinine clearance ≥ 70 mL/min
- •No other serious, uncontrolled illness
- •No active infection
- •No organ toxicity ≥ grade 2 except alopecia and neurological symptoms due to disease
- •Must be able to take oral medication
- •Patients with newly diagnosed brain stem glioma with difficulty swallowing may be eligible
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No evidence of pulmonary dysfunction or pre-existing lung disease
- •No myocardial infarction within the past year
- •No severe cardiac pathology
- •No significant ophthalmologic abnormality including, but not limited to, any of the following:
- •Severe dry eye syndrome
- •Keratoconjunctivitis sicca
- •Sjögren's syndrome
- •Severe exposure keratitis
- •Any other disorder likely to increase the risk of corneal epithelial lesions
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •More than 6 weeks since prior radiotherapy
- •No concurrent warfarin
- •No other concurrent anticancer or investigational agents
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy
次要结局
- Dose-limiting toxicities
- Safety
- Pharmacokinetic behavior of erlotinib hydrocloride
- Efficacy
- Correlation of expression and mutations of epidermal growth factor receptor with treatment response
研究者
研究点 (41)
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