Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma

NCT06933394 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Phase 2

Started

2025-05-01

Last updated

2025-04-18

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

Arsenic trioxideMAPK inhibitorsChemotherapy

Arsenic trioxide: Patients will receive 9 cycles of chemotherapy. ATO dosing: Arsenic trioxide（ATO） is administered 0.18mg/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.

MAPK inhibitors: The dosage of MAPK inhibitors is adjusted based on the specific drug. For example, Trametinib is used as follows: Trametinib will be administered daily from Cycle 5 until the end of induction chemotherapy. Patients start at Dose Level I; if no hematologic toxicity or severe drug-related complications occur after 1 cycle, the dose is escalated to the next level, otherwise, it is maintained. Dose Level I: 0.016 mg/kg/day (\<6 years) or 0.012 mg/kg/day (\>6 years), po. qd. Dose Level II: 0.024 mg/kg/day (\<6 years) or 0.018 mg/kg/day (\>6 years), po. qd. Dose Level III: 0.032 mg/kg/day (\<6 years) or 0.025 mg/kg/day (\>6 years), po. qd. The dosages of other MAPK inhibitors should be modified according to their respective recommended therapeutic guidelines.

Chemotherapy: The conventional chemotherapy regimens are as follows: Cycles 1, 2, 4, and 6 follow the CAV regimen (cyclophosphamide(1.2g/m2.d, d3-d4), pirarubicin(25mg/m2.d,d3-d5), vincristine(0.022mg/kg.d or 0.67mg/m2.d，d3-d5)). Cycles 3, 5, and 7 follow the PVP regimen (cisplatin(50mg/m2.d, d3-d6), etoposide(200mg/ m2.d, d3-d5)). Cycles 8 and 9 follow the CT regimen (cyclophosphamide(1.2g/m2.d, d3-d4), topotecan(2mg/m2.d, d3-d5)).

Study summary

This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of the combination therapy involving arsenic trioxide, MAPK inhibitors, and chemotherapy for stage 4/M neuroblastoma.

Eligibility

Sex

ALL

Min age

18 Months

Max age

18 Years

Healthy volunteers

Inclusion Criteria: 1. Patients with a pathological diagnosis of neuroblastoma. 2. Preoperative staging as INRG M stage or postoperative staging as INSS stage 4 (regardless of risk classification). 3. Age ≥18 months and ≤18 years. 4. Informed consent obtained from the legal guardian, and signed informed consent form. Exclusion Criteria: 1. Patients with a history of other tumors who have received chemotherapy and abdominal radiation therapy. 2. Severe progressive or persistent heart failure: NYHA heart function class III or IV, or left ventricular ejection fraction (LVEF) \< 50%. 3. Severe progressive or persistent renal failure: glomerular filtration rate (GFR) \< 30 ml/(min·1.73 m²) or serum creatinine \> 5 mg/dL (442 μmol/L). 4. Severe liver dysfunction: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 5× upper limit of normal (ULN), or serum total bilirubin ≥ 3× ULN.

Primary outcome measure(s)

Complete remission rate (CRR) — Four weeks after ATO-combined chemotherapy
Complete remission rate

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong	Recruiting

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Official registry record

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.

View NCT06933394 on ClinicalTrials.gov ↗ ← All trials in China