Tucidinostat Plus Etoposide in the Treatment of Relapsed or Refractory Neuroblastoma in Children
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.
• 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.