NCT00392340Unknown2 期
An Open-Label, Multicentre, Phase II Study of TVD as Treatment for Children With Stage 4 Neuroblastoma Failing to Respond to First-Line Treatment According to HR-NBL-01/ E-SIOP [Topotecan-Vincristine-Doxorubicin in Children With Stage 4 Neuroblastoma Failing to Respond to COJEC (TVD)]
Children's Cancer and Leukaemia Group21 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2008年3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
- 63
- 试验地点
- 21
- 主要终点
- Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, vincristine, and doxorubicin, 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 topotecan together with vincristine and doxorubicin works in treating young patients with refractory stage 4 neuroblastoma.
详细描述
OBJECTIVES:
Primary
- Assess whether treatment with topotecan hydrochloride, vincristine, and doxorubicin hydrochloride can achieve a satisfactory response rate in pediatric patients with stage 4 neuroblastoma that failed to respond to rapid first-line treatment.
Secondary
- Determine time to progression in these patients.
- Determine the toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage 4 neuroblastoma
- •Failed to achieve adequate metastatic partial response after first-line therapy while enrolled on protocol SIOP-EUROPE-HR-NBL-1
- •PATIENT CHARACTERISTICS:
- •Neutrophil count > 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Creatinine ≤ 1.36 mg/dL
- •Bilirubin ≤ 2.92 mg/dL
- •AST and ALT < 2.5 times upper limit of normal
- •Glomerular filtration rate ≥ 60 mL/min
- •Normal cardiac function on echocardiography
- •No severe organ dysfunction
- •No active hepatitis C or hepatitis B virus positivity
- •No HIV infection
- •PRIOR CONCURRENT THERAPY:
- •No anti-tumor chemotherapy within the past 10 days
- •No radiotherapy within the past 30 days
- •No other investigational drugs within the past 30 days
- •No prior doxorubicin hydrochloride
排除标准
- 未提供
结局指标
主要结局
Objective response rate (complete or partial) > 50% after 2 courses of topotecan hydrochloride, vincristine, and doxorubicin hydrochloride
次要结局
- Progression-free survival at the time of local progression or relapse, progression of pre-existing metastases, metastatic relapse, second primary malignancy, or death from any cause
- Toxicity and incidence of adverse events
研究者
研究点 (21)
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