NCT00276679已完成2 期
Phase II Study of Temozolomide (Temodal) in Children Over 1 Year of Age With Relapsed or Refractory High Risk Neuroblastoma
Children's Cancer and Leukaemia Group43 个研究点 分布在 3 个国家开始时间: 2003年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 43
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine tolerability of this drug in these patients
- Determine the tumor expression of the cellular repair mechanisms which repair DNA damage (O6-methylguanine-DNA methyltransferase [MGMT] and mismatch repair [MMR] systems) in patients treated with this drug.
- Correlate MGMT and MMR expression with outcomes in patients treated with this drug.
- Determine if MGMT and MMR expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug.
- Determine the activity of MGMT in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven neuroblastoma
- •High-risk relapsed or refractory disease, defined as 1 of the following:
- •Metastatic disease
- •Localized MYC-N amplified disease
- •Localized non MYC-N amplified disease at second relapse
- •Measurable primary or metastatic disease by cross-sectional imaging or MIBG scan
- •PATIENT CHARACTERISTICS:
- •Lansky performance status 40-100%
- •Life expectancy > 2 months
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during the course of this study and for 6 months after study completion
- •Organ toxicity < grade 2
- •Platelets ≥ 100,000/mm^3 (50,000/mm^3 after stem cell transplant or in case of marrow involvement)
- •Neutrophil count ≥ 500/mm^3
- •Bilirubin < 1.5 times normal
- •AST and ALT ≤ 2.5 times normal
- •No known HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •More than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose)
- •More than 30 days since prior radiotherapy except local palliative treatment for pain control
- •No more than 2 prior treatments for neuroblastoma
- •No other concurrent investigative treatment for neuroblastoma
排除标准
- 未提供
研究者
研究点 (43)
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