Combining arsenic trioxide, MAPK inhibitors, and chemotherapy for advanced neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination therapy using arsenic trioxide, MAPK inhibitors, and chemotherapy specifically for patients with stage 4/M neuroblastoma. The study aims to improve treatment outcomes by targeting the RAS-MAPK signaling pathway, which is often activated in tumors. It is a prospective, single-arm, multi-center trial that builds on previous findings indicating higher response rates with arsenic trioxide compared to standard regimens. The trial will assess the objective response rate and complete remission rate while monitoring for potential side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yang Li, Professor
• Email: drliyang@126.com
• Phone: 86-020-81332456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.