Adding Naxitamab to chemotherapy for high-risk 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 study explores the effectiveness of incorporating anti-GD2 immunotherapy, Naxitamab, during the induction phase of chemotherapy for children with newly diagnosed high-risk neuroblastoma. The goal is to determine if this addition can enhance the response rate at the end of induction therapy and improve overall survival rates. The study focuses on patients with specific biological characteristics that indicate a higher risk of poor outcomes. It is observational in nature, aiming to gather data on the treatment's impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis:

1. Children with newly diagnosed stage 4 neuroblastoma according to the International Neuroblastoma Staging System (INSS) who meet the following criteria are eligible for enrollment: i. Age \> 18 months (\> 547 days) regardless of biological characteristics; or ii. Age 12-18 months (365-547 days), with one of the following three unfavorable biological characteristics (MYCN amplification, pathological type of poor histopathological prognosis, and/or DNA index = 1); or iii. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics.
2. Children with newly diagnosed stage 3 INSS neuroblastoma who meet the following criteria are eligible for enrollment: i. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics; or ii. Age \> 18 months (\> 547 days), with pathological type of poor histopathological prognosis regardless of MYCN status.
3. Children with newly diagnosed stage 2A/2B INSS neuroblastoma with MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics. The subject must be aged ≤ 21 years at the time of initial diagnosis, and must be aged \> 12 months at the time of enrollment.

Exclusion criteria:

Infants less than 1 year old, those aged 12-18 months, INSS stage 4, and all INSS stage 3 patients with favorable biological characteristics (i.e., non-amplified MYCN, good pathological histopathological prognosis, and DNA index \>1) are not eligible.

Subjects who have received immunosuppressive treatment (excluding local steroids) within the last 4 weeks prior to enrollment. Subjects who are currently receiving any investigational drug.

Any other medical condition that, in the opinion of the investigator, may interfere with the interpretation of results or affect the subject's ability to provide informed consent, the legal guardian's ability to provide informed consent, and the subject's cooperation and participation in the study, including but not limited to malabsorption syndrome, mental illness, or substance abuse. Subjects with significant comorbidities (any serious medical condition unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and is expected to interfere with the investigation drug(s) action or significantly increase the severity of the trial treatment toxicity)

Where it's running

• Guangzhou Women And Children's Medical Center
  Guanzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Wenyue Si, Bachelor
• Email: feky@gwcmc.org
• Phone: +86-(020)-38367270

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.