NCT00514397Unknown2 期
A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide With Radiotherapy in Diffuse Pontine Gliomas
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 41
- 主要终点
- Overall survival
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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating young patients with pontine glioma.
详细描述
OBJECTIVES:
Primary
- To evaluate the time to death in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To assess the quality of life of patients with diffuse pontine gliomas during and after treatment.
Secondary
- To evaluate the time to tumor progression in patients with newly diagnosed diffuse pontine gliomas, when treated with the combination of concomitant low-dose oral temozolomide and radiotherapy, followed by up to 12 months of maintenance therapy with extended low-dose temozolomide.
- To evaluate and document toxicities from the administration of temozolomide combined with radiotherapy and to further study any toxicities associated with the chronic administration of the extended low-dose temozolomide schedule in this population group.
- To document radiological response to the above treatment with MR imaging and, where available, functional imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Newly diagnosed diffuse intrinsic lesion centered in the pons on MRI
- •No requirement for histological diagnosis
- •Clinical history < 6 months
- •Clinical findings must include at least 1 of the 3 following signs of brainstem tumor:
- •Cranial nerve deficit
- •Long tract signs
排除标准
- •Focal lesions of brainstem
- •Predominantly exophytic tumors
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Karnofsky performance status (PS) or Lansky PS 60-100% (unless reason for decrease in status is a direct result of neurological involvement of the brainstem glioma)
- •Life expectancy > 12 weeks
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Urea and serum creatinine < 1.5 times upper limit of normal (ULN)
- •Total and direct bilirubin < 1.5 times ULN
- •AST and ALT < 3 times ULN
- •Negative pregnancy test within 7 days prior to administration of temozolomide for women of childbearing potential
- •Exclusion criteria:
- •Frequent vomiting and/or medical condition, that could interfere with oral medication intake (e.g., partial bowel obstruction)
- •Pregnant or breast-feeding women
- •PRIOR CONCURRENT THERAPY:
- •Exclusion criteria:
- •Prior chemotherapy or radiotherapy
- •Other concurrent investigational drugs
- •Other concurrent chemotherapy, immunotherapy, or biologic therapy
结局指标
主要结局
Overall survival
Quality of life including health status, behavior, and the subjective experience using HUI and SDQ methods
次要结局
- Adverse events, including abnormal laboratory parameters, as assessed by CTC criteria
- Toxicity, steroid usage, and radiological response
研究者
研究点 (41)
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