Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 3~18 years old; 2. 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; 3. Histologically confirmed neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines; 4. Patients must have a history of high-risk neuroblastoma, at least one measurable lesions according to the RECIST 1.1; 5. Patients who have progressed, recurrent or refractory disease after first-line treatment; 6. The residual disease biopsy must be done, if patiens who have persistent disease obtain incomplete response after first line treatment; 7. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration； 8. Patients have not received enzyme-induced anticonvulsant therapy; 9. Patients have not received valproic acid within 30 days before admission; 10. 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. 11. Patients' guardians must be willing and able to understand and comply with the protocol for the duration of the study.

Exclusion Criteria:

1. Patients with severe cardiovascular disease; 2. Patients who have previously received organ transplants; 3. Inability to swallow pills; 4. 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; 5. Active HIV, hepatitis B or hepatitis C; 6. Researchers believe that patients are unsuitable for any other situation in this study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05338541
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yizhuo Zhang
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yizhuo Yizhuo
Principal Investigator Affiliation	Sun Yat-sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma in Children

Arms & Interventions

Arms

Experimental: Tucidinostat and etoposide

Interventions

Drug: - Tucidinostat and etoposide

Tucidinostat: 3+3 design，14 mg/m2，17.5 mg/m2，23 mg/m2 etoposide: 50mg/m2,

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen University, Guangzhou, China

Status

Recruiting

Address

Sun Yat-sen University

Guangzhou, ,

Site Contact

Yizhuo Zhang

zhangyzh@sysucc.org.cn

020-87342460

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