Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood. (CSIIT-Q36)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    30
  • sponsor
    Yizhuo Zhang
Updated on 1 July 2022

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 crest differentiation due to abnormal gene regulation.

Details
Condition Neuroblastoma in Children
Treatment Tucidinostat and etoposide
Clinical Study IdentifierNCT05338541
SponsorYizhuo Zhang
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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