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The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Neuroblastoma | Experimental | Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DANYELZA | Biological | DANYELZA is a humanized monoclonal antibody of the IgG1 subclass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate participant response | To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients. | After 2 cycles of mAb-based therapy (each cycle is 21 days) |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Kushner, MD | Contact | 8336755491 | kushnerb@MSKCC.ORG | |
| Fiorella Iglasias Cardenas, MD, MS | Contact | iglesiaf@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Kushner, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Sargramostim | Biological | Yeast derived recombinant human Sargramostim (GM-CSF) |
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| Cytoxan | Drug | Cyclophosphamide is an alkylating agent related to nitrogen mustard |
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| Topotecan | Drug | Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin. |
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| Vincristine | Drug | Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle). |
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| Doxorubicin | Drug | Doxorubicin is an anthracycline antibiotic |
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| Ifosfamide | Drug | Ifosfamide is a structural analogue of cyclophosphamide |
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| Etoposide | Drug | Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each). |
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| Carboplatin | Drug | Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials. |
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| Irinotecan | Drug | Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor |
|
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| Temozolomide | Drug | Temozolomide is administered intravenously |
|
|
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000718263 | naxitamab |
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003520 | Cyclophosphamide |
| D019772 | Topotecan |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D016190 | Carboplatin |
| D000077146 | Irinotecan |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D056831 | Coordination Complexes |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
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