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

• ClinicalTrials.gov Identifier: NCT03503864
• Recruitment Status: Recruiting
• First Posted: April 20, 2018
• Last Update Posted: July 30, 2021
• Sponsor: Yang Li
• Information provided by (Responsible Party): Yang Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neuroblastoma	Drug: Arsenic Trioxide	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Combined induction chemotherapy with arsenic trioxide
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 30, 2028
• Estimated Study Completion Date: December 30, 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: ATO-combined chemotherapy; Patients receive combined induction chemotherapy with arsenic trioxide.	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.; Other Name: ATO

Outcome Measures

Primary Outcome Measures :

1. Objective response rate [ Time Frame: Four weeks after ATO-combined induction chemotherapy ]

Secondary Outcome Measures :

1. Overall survival [ Time Frame: 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. ]
   Survival time from patients diagnosed with stage 4/M neuroblastoma untill death
2. Progression free survival [ Time Frame: 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. ]
   Survival time from patients diagnosed with stage 4/M neuroblastoma untill disease progression or death
3. Incidence of adverse events [ Time Frame: From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years. ]
   Adverse events are monitored and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

Eligibility Criteria

• Ages Eligible for Study: up to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Yang Li, Professor; +8602081332456; drliyang@126.com

Locations

China, Guangdong

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

Guangzhou, Guangdong, China, 510120

Contact: Yang Li, Professor +8602081332456 drliyang@126.com

Sponsors and Collaborators

Yang Li

More Information

• Responsible Party: Yang Li, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT03503864
• Other Study ID Numbers: SYS-C-202007
• First Posted: April 20, 2018
• Last Update Posted: July 30, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Yang Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:

Neuroblastoma; Arsenic Trioxide; Children

Additional relevant MeSH terms:

Neuroblastoma; 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; Arsenic Trioxide; Antineoplastic Agents