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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• 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.

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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

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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