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

Neuroblastoma Clinical Trial

Official title:

Clinical Research on Efficacy and Safety of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma：A Prospective，Single-arm, Open-label, Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03503864
• Other study ID #: SYS-C-202007
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: December 30, 2028

Study information

• Verified date: November 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yang Li, Professor
• Phone: +8602081332456
• Email: drliyang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is a prospective, single-arm, open-lable, multi-center clinical trial. Children≤ 14 years old are eligible for this study if they were newly diagnosed with neuroblastoma and assessed as stage 4 according to the International Neuroblastoma Staging System (INSS) or stage M according to the International Neuroblastoma Risk Group (INRG) respectively. Patients enrolled in this study will receive combined induction chemotherapy with arsenic trioxide following an modifed protocol based on N7 and NB2004 protocols. Objective response rate (ORR) at 4 weeks after completing induction chemotherapy was defined as the main outcome and adverse events were monitored and graded in the meantime.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System(INSS) or the International Neuroblastoma Risk Group (INRG) staging system;

2. Patients not more than 14 years old;

3. There are measurable lesions;

4. Guardians agreed and signed informed consent.

Exclusion Criteria:

1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.

2. Patients with one or more critical organs failure such as heart, brain, kidney failure.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Arsenic Trioxide
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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yang Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		Four weeks after ATO-combined induction chemotherapy
Secondary	Overall survival	Survival time from patients diagnosed with stage 4/M neuroblastoma untill death	From the date of patients enrolled until the date of death from any cause,From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary	Progression free survival	Survival time from patients diagnosed with stage 4/M neuroblastoma untill disease progression or death	From the date of patients enrolled to the date of of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary	Incidence of adverse events	Adverse events are monitored and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)	From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.