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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Months and 19 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants with Neuroblastoma 		Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
  • Biological: DANYELZA
    DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
    Other names:
    • Naxitamab
  • Biological: Sargramostim
    Yeast derived recombinant human Sargramostim (GM-CSF)
    Other names:
    • granulocyte-macrophage colony-stimulating factor
    • GM-CSF
  • Drug: Cytoxan
    Cyclophosphamide is an alkylating agent related to nitrogen mustard
    Other names:
    • Cyclophosphamide
  • Drug: Topotecan
    Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
  • Drug: Vincristine
    Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
    Other names:
    • Oncovin
  • Drug: Doxorubicin
    Doxorubicin is an anthracycline antibiotic
    Other names:
    • Adriamycin
  • Drug: Ifosfamide
    Ifosfamide is a structural analogue of cyclophosphamide
    Other names:
    • Isophosphamide
  • Drug: 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).
    Other names:
    • VePesid
    • Etopophos
    • VP-16
  • Drug: Carboplatin
    Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
    Other names:
    • Paraplatin
  • Drug: Irinotecan
    Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
    Other names:
    • Camptosar
  • Drug: Temozolomide
    Temozolomide is administered intravenously
    Other names:
    • Temodar

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Brian Kushner, MD
212-639-6793

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Brian Kushner, MD
8336755491
kushnerb@MSKCC.ORG

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.