NCT00003737已完成2 期
A Pharmacokinetic-Guided Phase II Trial of the Rebeccamycin Analog NSC# 655649 in Pediatric Patients With Relapsed/Refractory Neuroblastoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response (complete response, very good partial response, or partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating children who have relapsed or refractory neuroblastoma.
详细描述
OBJECTIVES:
- Determine the response rate to rebeccamycin analogue in children with relapsed or refractory neuroblastoma.
- Determine the toxicity of this drug in these patients.
- Identify and establish in vitro biologic correlates of clinical responses and toxicity of this drug in these patients.
OUTLINE: Patients receive rebeccamycin analogue IV over 1 hour once on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: This study will accrue up to 30 patients within 1.5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven relapsed or refractory neuroblastoma
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 1.5 mg/dL
- •SGOT and SGPT less than 2.5 times upper limit of normal (ULN)
- •Adequate liver function unless due to disease
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 60 mL/min
- •Adequate renal function unless due to disease
- •No other serious concurrent illness
- •No active uncontrolled infection
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Recovered from prior immunotherapy
- •Prior autologous bone marrow transplantation allowed
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy and recovered
- •No other concurrent systemic chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response (complete response, very good partial response, or partial response)
Freedom from progression
Time to treatment failure
次要结局
- Toxicity
研究者
研究点 (1)
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