Tucidinostat Plus Etoposide in the Treatment of Neuroblastoma in Childhood.

NCT ID: NCT05338541

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2024-12-31

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 crest differentiation due to abnormal gene regulation.

Conditions

Neuroblastoma in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tucidinostat and etoposide

Group Type: EXPERIMENTAL

Tucidinostat and etoposide

Intervention Type: DRUG

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

Interventions

Tucidinostat and etoposide

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yizhuo Zhang

OTHER

Sponsor Role: lead

Responsible Party

Yizhuo Zhang

Director of department of pediatric cancer,Principal Investigator,Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yizhuo Yizhuo

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yizhuo zhang

Role: CONTACT

zhangyzh@sysucc.org.cn

020-87342460

Facility Contacts

Yizhuo Zhang

Role: primary

Other Identifiers

CHIDA-01

Identifier Type: -

Identifier Source: org_study_id