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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: High-risk Neuroblastoma; Neuroblastoma; Childhood Neuroblastoma

Treatments: Drug: Doxorubicin; Drug: Vincristine; Drug: Irinotecan; Drug: Topotecan; Drug: Carboplatin; Drug: Temozolomide; Biological: Sargramostim; Biological: DANYELZA; Drug: Etoposide; Drug: Ifosfamide; Drug: Cytoxan

Study type: Interventional

Funder types: Other

Identifiers

NCT06528496

24-144

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 months to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Participants with Neuroblastoma

Experimental group

Description:

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

Treatment:

Drug: Cytoxan

Drug: Ifosfamide

Drug: Etoposide

Biological: Sargramostim

Biological: DANYELZA

Drug: Temozolomide

Drug: Carboplatin

Drug: Irinotecan

Drug: Topotecan

Drug: Vincristine

Drug: Doxorubicin