A Phase II Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
研究概览
简要总结
The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet the following inclusion criteria.
- •The subject must have a confirmed diagnosis of acute lymphoblastic leukemia within 1 week of starting therapy
- •Currently being treated on a standard ALL induction regimen
- •Subjects must be greater than or equal to 5 and less than 18 years old
- •Signed informed consent
排除标准
- •Subjects will be excluded for the following:
- •Preexisting neurologic disease, including grade II, III, or IV neurological status by NCI Common Toxicity Criteria v3.0 on clinical exam
- •History of hypersensitivity to vincristine
- •History of hypersensitivity to Acetyl-L-carnitine
- •Previous use of Acetyl-L-carnitine
- •Concurrent anti-convulsant use
- •Concurrent Gabapentin use
- •Concurrent Glutamine use
- •Liver Function: Total bilirubin greater than 1.3 mg/dL and serum glutamic-pyruvic transaminase (SGPT) (ALT) greater than 5 x upper limit of normal for age and serum albumin less than 2 g/dL
- •Patients who are pregnant
研究组 & 干预措施
Acetyl-L-Carnitine only
The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.
干预措施: Acetylcarnitine (Drug)
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
干预措施: Acetylcarnitine (Drug)
Acetyl-L-Carnitine or Placebo
Subjects 16-30 will be randomized to receive drug or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
时间窗: Days 1 - 21
次要结局
未报告次要终点
研究者
Chie-Schin Shih
Assistant Professor
Indiana University