N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
NCT ID: NCT06528496
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-07-22
2029-07-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Participants with Neuroblastoma
Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
DANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Sargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
Cytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
Topotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
Vincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Doxorubicin
Doxorubicin is an anthracycline antibiotic
Ifosfamide
Ifosfamide is a structural analogue of cyclophosphamide
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).
Carboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Irinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Temozolomide
Temozolomide is administered intravenously
Interventions
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DANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Sargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
Cytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
Topotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
Vincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Doxorubicin
Doxorubicin is an anthracycline antibiotic
Ifosfamide
Ifosfamide is a structural analogue of cyclophosphamide
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).
Carboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Irinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Temozolomide
Temozolomide is administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to comply with protocol requirements
* Pregnancy
18 Months
19 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Kushner, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Brian Kushner, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-144
Identifier Type: -
Identifier Source: org_study_id