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.
Study summary
This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.
Eligibility
Sex
ALL
Min age
—
Max age
14 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate — 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.
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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