NCT05338541招募中1 期
Tucidinostat Plus Etoposide in the Treatment of Relapsed or Refractory Neuroblastoma in Children
Yizhuo Zhang1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
Neuroblastoma is a malignant tumor that develops in infants and kids. Dysregulation of histone acetylation is associated with a series of malignant tumors. Neuroblastoma is caused by defective neural crest differentiation due to abnormal gene regulation.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3~18 years old;
- •Patients must have a life expectancy of at least 6 weeks and a Lansky (≤16 years) or Karnofsky (>16 years) score of at least 50;
- •Histologically confirmed neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines;
- •Patients must have a history of high-risk neuroblastoma, at least one measurable lesions according to the RECIST 1.1;
- •Patients who have progressed, recurrent or refractory disease after first-line treatment;
- •The residual disease biopsy must be done, if patiens who have persistent disease obtain incomplete response after first line treatment;
- •Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration；
- •Patients have not received enzyme-induced anticonvulsant therapy;
- •Patients have not received valproic acid within 30 days before admission;
- •ANC ≥ 1.5×10^9/L, PLT ≥75×10^9/L;TBIL≤1.5ULN, ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN 9）LVEF ≥ 50% and QTc≤470 ms.
- •Patients' guardians must be willing and able to understand and comply with the protocol for the duration of the study.
排除标准
- •Patients with severe cardiovascular disease;
- •Patients who have previously received organ transplants;
- •Inability to swallow pills;
- •Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
- •Active HIV, hepatitis B or hepatitis C;
- •Researchers believe that patients are unsuitable for any other situation in this study.
研究组 & 干预措施
Tucidinostat and etoposide
Experimental
干预措施: Tucidinostat and etoposide (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 1 year
Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity.
Maximum Tolerated Dose (MTD)
时间窗: 1 year
Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT.
次要结局
- disease control rate (DCR)(2 years)
- overall survival (OS)(2 years)
- Response Rate(ORR)(2 years)
- progression-free survival (PFS)(2 years)
研究者
Yizhuo Zhang
Director of department of pediatric cancer,Principal Investigator,Clinical Professor
Sun Yat-sen University
研究点 (1)
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