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

Phase 2

Recruiting

• Conditions: Neuroblastoma; Childhood Neuroblastoma; High-risk Neuroblastoma
• Interventions: Biological: DANYELZA; Biological: Sargramostim; Drug: Cytoxan; Drug: Topotecan; Drug: Vincristine; Drug: Doxorubicin; Drug: Ifosfamide; Drug: Etoposide; Drug: Carboplatin; Drug: Irinotecan; Drug: Temozolomide

• Registration Number: NCT06528496
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2029-07-22
• Study Completion: 2029-07-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants with Neuroblastoma	Topotecan	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Vincristine	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Carboplatin	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	DANYELZA	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Doxorubicin	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Etoposide	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Cytoxan	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Sargramostim	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Ifosfamide	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Temozolomide	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Participants with Neuroblastoma	Irinotecan	Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.

Primary Outcome Measures

Name	Time	Method
Evaluate participant response	After 2 cycles of mAb-based therapy (each cycle is 21 days)	To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States