Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma

NCT03503864 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: SYS-C-202007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.

Conditions

Neuroblastoma

Keywords

Neuroblastoma; Arsenic Trioxide; Children

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The percentage of patients who had complete remission（CR）or partial remission（PR）after induction chemotherapy combined ATO. Per Response Evaluation Criteria In Solid Tumors Criteria (WHO criteria) for target lesions and assessed by MRI or CT: CR: All lesions completely disappear, maintained for at least 4 weeks. PR: Estimated tumor size reduction by more than 50%, maintained for at least 4 weeks.

  Four weeks after ATO-combined induction chemotherapy

Secondary Outcomes (3)

• Overall Survival Rate

  3 years.

• Progression Free Survival Rate

  3 years.

• Number of Participants With Adverse Events

  From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.

Study Arms (1)

ATO-combined chemotherapy

EXPERIMENTAL

Patients receive combined induction chemotherapy with arsenic trioxide.

Drug: Arsenic Trioxide

Interventions

Arsenic Trioxide DRUG

Arsenic trioxide（ATO） is administered 0.16mg/kg per day over eight hours IV daily for ten days. Patients will receive ATO alone on days 1-2 and combined with conventional induction chemotherapy on days 3-10. Nine cycles at most of ATO-combined chemotherapy were applied in the whole scheme.

Also known as: ATO

ATO-combined chemotherapy

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system;
• Patients not more than 14 years old;
• There are measurable lesions;
• Guardians agreed and signed informed consent.

You may not qualify if:

• Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.
• Patients with one or more critical organs failure such as heart, brain, kidney failure.

Sponsors & Collaborators

• Yang Li: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr Yang Li
• Organization: Sun Yat-sen Memorial Hospital

drliyang@126.com

02081332045

Study Officials

• Yang Li, Professor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Combined induction chemotherapy with arsenic trioxide

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: April 20, 2018
• Study Start: June 12, 2017
• Primary Completion: August 30, 2023
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)