RecruitingPhase 2NCT06528496

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

N10: Reduced Therapy for High-Risk Neuroblastoma


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

45 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 MonthsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for children with high-risk neuroblastoma (a type of cancer that develops in nerve tissue, most often in young children) that uses reduced chemotherapy combined with targeted antibody therapy, aiming to achieve good results with fewer side effects. **You may be eligible if...** - Your child has been diagnosed with neuroblastoma (confirmed by biopsy, bone marrow, or imaging) - Your child has high-risk neuroblastoma with MYCN gene amplification or is older than 18 months with stage M disease - Your child has received no more than one prior cycle of high-risk neuroblastoma chemotherapy **You may NOT be eligible if...** - Your child has already received extensive chemotherapy for this condition - Your child has another serious illness that would prevent treatment - The cancer does not meet the high-risk criteria defined in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDANYELZA

DANYELZA is a humanized monoclonal antibody of the IgG1 subclass

BIOLOGICALSargramostim

Yeast derived recombinant human Sargramostim (GM-CSF)

DRUGCytoxan

Cyclophosphamide is an alkylating agent related to nitrogen mustard

DRUGTopotecan

Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.

DRUGVincristine

Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).

DRUGDoxorubicin

Doxorubicin is an anthracycline antibiotic

DRUGIfosfamide

Ifosfamide is a structural analogue of cyclophosphamide

DRUGEtoposide

Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).

DRUGCarboplatin

Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.

DRUGIrinotecan

Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor

DRUGTemozolomide

Temozolomide is administered intravenously


Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT06528496


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