Valproic Acid for Children With Recurrent and Progressive Brain Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Completion of protocol
研究概览
简要总结
The study investigates valproic acid added to radiation and temozolomide therapy (standard of care) for progressive or recurrent pediatric brain tumors.
详细描述
Patients with progressive or recurrent pediatric brain tumors are administered valproic acid, an HDAC inhibitor, along with standard of care therapy (radiation and temozolomide) for induction therapy. Thereafter, patients will be able to continue on valproic acid and temozolomide therapy as long as the combination is well tolerated and the tumor is not progressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, parent, or guardian willing and able to give informed consent
- •Recurrent or progressive pediatric brain tumor, with MRI evidence of disease
- •Age at first diagnosis of brain tumor 1-21 years old
- •Lansky or Karnofsky performance score of at least 50 at diagnosis
排除标准
- •Pregnancy
- •Prior intolerance to valproic acid
- •History of use of temozolomide
- •Use of enzyme inducing anticonvulsant medications (see appendix B)
- •Known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)
研究组 & 干预措施
Treatment arm
All participants will be enrolled on to one, open-label arm. Participants will be treated with valproic acid in addition to standard of care therapy.
干预措施: Valproic Acid (Drug)
结局指标
主要结局
Completion of protocol
时间窗: 2 months
Number of participants completing the protocol will be measured.
次要结局
- Time to progression(2 months)
研究者
Amy-Lee Bredlau
Director, Pediatric Brain Tumor Program
Medical University of South Carolina