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
Overview
- Phase
- Phase 2
- Intervention
- Arsenic Trioxide
- Conditions
- Neuroblastoma
- Sponsor
- Yang Li
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
- Status
- Active, Not Recruiting
- Last Updated
- 11 months ago
Overview
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.
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.
Investigators
Yang Li
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
ATO-combined chemotherapy
Patients receive combined induction chemotherapy with arsenic trioxide.
Intervention: Arsenic Trioxide
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: Four weeks after ATO-combined induction chemotherapy
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.
Secondary Outcomes
- 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.)