NCT00990912已完成1 期
A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002
Bristol-Myers Squibb0 个研究点目标入组 20 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Assessment of safety and tolerability
研究概览
简要总结
The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
- •Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
- •Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
- •Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002
排除标准
- •A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
- •Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
- •Inadequate bone marrow and renal function
- •Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
研究组 & 干预措施
Carboplatin
Experimental
干预措施: Carboplatin (Drug)
Irinotecan (12 (9) mg/m²/day)
Experimental
干预措施: Irinotecan (Drug)
Irinotecan (10 (10) mg/m²/day
Active Comparator
干预措施: Irinotecan (Drug)
结局指标
主要结局
Assessment of safety and tolerability
时间窗: 22 months
次要结局
- Assessment of duration of clinical benefit per CT or MRI, steroid use and neuropathy assessment(Every other cycle for 22 months)
研究者
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