Reduced chemotherapy and antibody treatment for children with high-risk neuroblastoma
N10: Reduced Therapy for High-Risk Neuroblastoma
This study is testing a new, lighter chemotherapy and antibody treatment for children with high-risk neuroblastoma to see if it helps them get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Months to 19 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06528496 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children under 19 years old with a confirmed diagnosis of high-risk neuroblastoma and limited prior chemotherapy exposure.
Not a fit: Patients with severe organ dysfunction or those unable to comply with the study protocol may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for children with high-risk neuroblastoma.
How similar studies have performed: Other studies have shown promise with reduced chemotherapy and monoclonal antibody therapies in treating neuroblastoma, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.