Reduced chemotherapy and antibody treatment for children with 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 evaluates the safety and effectiveness of a reduced chemotherapy regimen combined with monoclonal antibody therapy for children diagnosed with high-risk neuroblastoma. The treatment involves administering DANYELZA, Sargramostim, Cytoxan, Topotecan, and Vincristine to assess their impact on disease progression and patient outcomes. Participants must meet specific eligibility criteria, including age and prior treatment history, to ensure the study's integrity and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
* HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients \>18 months old.
* No more than one prior cycle of HR-NB chemotherapy
* Age \<19 years.
* Signed informed consent indicating awareness of the investigational nature of this treatment.

Exclusion Criteria:

* Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3

  °Organ dysfunction due to direct effects of primary tumor or metastatic disease, or due to paraneoplastic syndromes associated with neuroblastoma, will not be considered in exclusion criteria. Similarly, complications of interventions to control above direct effects (e.g., steroid- induced hyperglycemia or hypertension) will also not be considered in exclusion criteria
* Inability to comply with protocol requirements
* Pregnancy

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Brian Kushner, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Brian Kushner, MD
• Email: kushnerb@MSKCC.ORG
• Phone: 8336755491

Similar studies

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

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• Dinutuximab-beta with chemotherapy in newly diagnosed high-risk neuroblastoma

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• CIML-NK Cells to Treat Neuroblastoma in Relapsed or Refractory Patients

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• Becotatug Vedotin for EGFR-positive relapsed, refractory, or metastatic pediatric solid tumors

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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.