Status:
RECRUITING
Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.
Lead Sponsor:
Yizhuo Zhang
Conditions:
Neuroblastoma in Children
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05338541
Start Date
May 27 2022
End Date
December 1 2024
Last Update
February 7 2024
Active Locations (1)
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1
Sun Yat-sen University
Guangzhou, China