N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DANYELZA, Sargramostim, Cytoxan, Topotecan.
- Who it may be relevant to
- Registry conditions: High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma. Basic parameters: 18 months — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
N10: Reduced Therapy for High-Risk Neuroblastoma
Overview
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Interventions
- Biological DANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass - Biological Sargramostim
Yeast derived recombinant human Sargramostim (GM-CSF) - Drug Cytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard - Drug Topotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin. - Drug Vincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle). - Drug Doxorubicin
Doxorubicin is an anthracycline antibiotic - Drug Ifosfamide
Ifosfamide is a structural analogue of cyclophosphamide - Drug Etoposide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each). - Drug Carboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials. - Drug Irinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Primary outcome measures
- Evaluate participant response [Time frame: After 2 cycles of mAb-based therapy (each cycle is 21 days)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT06528496 · 24-144