NCT05338541

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

April 13, 2022

Last Update Submit

February 5, 2024

Conditions

Neuroblastoma in Children

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity (DLT)

    Dose-limiting toxicity defined as any Grade 4 hematological toxicity and any \> Grade 3 non-hematologic toxicity.

    1 year

  • Maximum Tolerated Dose (MTD)

    Maximum tolerated dose is highest dose level in which 6 patients treated with at most 1 experiencing DLT.

    1 year

Secondary Outcomes (4)

  • Response Rate(ORR)

    2 years

  • progression-free survival (PFS)

    2 years

  • overall survival (OS)

    2 years

  • disease control rate (DCR)

    2 years

Study Arms (1)

Tucidinostat and etoposide

EXPERIMENTAL
Drug: Tucidinostat and etoposide

Interventions

Tucidinostat and etoposideDRUG

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

Tucidinostat and etoposide

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideEtoposide

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Yizhuo Yizhuo

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yizhuo zhang

CONTACT

020-87342460zhangyzh@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of department of pediatric cancer,Principal Investigator,Clinical Professor

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 21, 2022

Study Start

May 27, 2022

Primary Completion

June 30, 2024

Study Completion

December 1, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)