Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.

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Description

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.

Targeted Conditions

Study Overview

Start Date
May 27, 2022
Completion Date
December 1, 2024
Enrollment
30
Date Posted
April 21, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Sun Yat-sen University
Guangzhou, China

Eligibility

Minimum Age (years)
3
Maximum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

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 Criteria:

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.

Study Contact Info

Study Contact Name
Yizhuo zhang
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05338541