N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

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N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma

Study Purpose

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Months - 19 Years
Gender	All

More 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 > grade 2.

- Inability to comply with protocol requirements.

- Pregnancy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06528496
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Brian Kushner, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Participants with Neuroblastoma

Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.

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

Drug: - Temozolomide

Temozolomide is administered intravenously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Brian Kushner, MD

[email protected]

212-639-6793