NCT00360945Unknown2 期
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
Children's Cancer and Leukaemia Group45 个研究点 分布在 3 个国家目标入组 87 人开始时间: 2004年4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
- 87
- 试验地点
- 45
- 主要终点
- Response rate after 2 courses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate (complete and partial response) in pediatric patients with malignant gliomas treated with temozolomide and cisplatin.
Secondary
- Identify genetic, metabolic, and proteomic profiles that will provide an insight into the molecular pathways involved in the pathogenesis of these tumors.
- Link genetic changes with clinical details, histopathology, and patient outcome, thereby developing a biological basis for diagnosis, prognosis, and treatment monitoring.
- Evaluate relapse-free survival at 1 and 2 years in patients treated at diagnosis.
- Evaluate the duration of clinical response in patients treated at relapse.
- Study the health status and quality of life of these patients.
- Evaluate long-term toxicity of this therapeutic combination.
- Evaluate the ability of magnetic resonance spectroscopy vs CT scan to predict response in patients with high-grade astrocytomas.
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
- 4 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors*:
- •Glioblastoma
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic oligoastrocytoma
- •Anaplastic ganglioglioma
- •Anaplastic mixed tumor
- •Glial component is essential NOTE: *Malignant gliomas occurring as a second primary malignancy allowed
- •Newly diagnosed or recurrent disease
- •No malignant brain stem tumors
- •Incompletely resected tumors
- •No completely resected tumors
- •Measurable or evaluable disease by conventional MRI
- •PATIENT CHARACTERISTICS:
- •Lansky performance status 40-100%
- •Organ toxicity ≤ grade 2
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN
- •Prothrombin ≥ 50%
- •Fibrinogen ≥ 1.5 g/L
- •Creatinine normal for age
- •Creatinine ≤ 65 µmol/L (4-15 years of age)
- •Creatinine ≤ 110 µmol/L (15-20 years of age)
- •Audiogram with toxicity grade ≤ 2
- •ECG normal
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No severe or life-threatening infection
- •No uncontrolled developing or symptomatic intracranial hypertension
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease
- •No prior cisplatin or temozolomide
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Response rate after 2 courses
次要结局
- Relapse-free survival
- Rate of progression at 6 months and 1 and 2 years
- Best response in patients receiving more than 2 courses
- Overall survival
研究者
研究点 (45)
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