High-risk NeuroblastomaPhase 2NCT06528496
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
A Phase 2 study testing DANYELZA, Sargramostim and Cytoxan in people with High-risk Neuroblastoma and Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 19 years
- Conditions the study is for
- High-risk Neuroblastoma, Neuroblastoma, Childhood Neuroblastoma
- What is being tested?
- DANYELZA, Sargramostim and Cytoxan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2024to 22 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fiorella Iglasias Cardenas, MD, MS contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Brian Kushner, MD, 212-639-6793
About this study
Official title: N10: Reduced Therapy for High-Risk Neuroblastoma
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
- Being tested
- DANYELZA, Sargramostim, Cytoxan, Topotecan, Vincristine
- Keywords
- High-risk neuroblastoma, neuroblastoma, childhood neuroblastoma, N10, Memorial Sloan Kettering Cancer Center, 24-144
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DANYELZABiological
Also called Naxitamab
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
SargramostimBiological
Also called granulocyte-macrophage colony-stimulating factor, GM-CSF
Yeast derived recombinant human Sargramostim (GM-CSF)
CytoxanDrug
Also called Cyclophosphamide
Cyclophosphamide is an alkylating agent related to nitrogen mustard
TopotecanDrug
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
VincristineDrug
Also called Oncovin
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
DoxorubicinDrug
Also called Adriamycin
Doxorubicin is an anthracycline antibiotic
IfosfamideDrug
Also called Isophosphamide
Ifosfamide is a structural analogue of cyclophosphamide
EtoposideDrug
Also called VePesid, Etopophos, VP-16
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
CarboplatinDrug
Also called Paraplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
IrinotecanDrug
Also called Camptosar
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
TemozolomideDrug
Also called Temodar
Temozolomide is administered intravenously
Radiation TherapyRadiation
Between first and second cycle of antibody
| Study group | Role | What they receive |
|---|---|---|
| Participants with Neuroblastoma | Experimental | Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention. Receives: Biological: DANYELZA; Biological: Sargramostim; Drug: Cytoxan; Drug: Topotecan; Drug: Vincristine; Drug: Doxorubicin; Drug: Ifosfamide; Drug: Etoposide; Drug: Carboplatin; Drug: Irinotecan; Drug: Temozolomide; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate participant response
To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.
Measured: After 2 cycles of mAb-based therapy (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start22 Jul 2024
- Primary completion22 Jul 2029 (estimated)
- Study completion22 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Kushner, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528496
- Sponsor's protocol ID
- 24-144
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N10: Reduced Therapy for High-Risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT06528496
- Acronym / sponsor ID
- 24-144
- Keywords
- High-risk neuroblastoma, neuroblastoma, childhood neuroblastoma, N10, Memorial Sloan Kettering Cancer Center, 24-144
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 22 Jul 2029 (estimated)
- Study completion
- 22 Jul 2029 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Neuroblastoma | Experimental | Biological: DANYELZA, Biological: Sargramostim, Drug: Cytoxan, Drug: Topotecan, Drug: Vincristine, Drug: Doxorubicin, Drug: Ifosfamide, Drug: Etoposide, Drug: Carboplatin, Drug: Irinotecan, Drug: Temozolomide, Radiation: Radiation TherapyParticipants will receive 4 cycles of induction chemotherapy followed by a response-based intervention. |
Who may qualify
- Ages
- 18 months to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DANYELZAAlso: NaxitamabDANYELZA is a humanized monoclonal antibody of the IgG1 subclass | Biological | Participants with Neuroblastoma |
| SargramostimAlso: granulocyte-macrophage colony-stimulating factor, GM-CSFYeast derived recombinant human Sargramostim (GM-CSF) | Biological | Participants with Neuroblastoma |
| CytoxanAlso: CyclophosphamideCyclophosphamide is an alkylating agent related to nitrogen mustard | Drug | Participants with Neuroblastoma |
| TopotecanTopotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin. | Drug | Participants with Neuroblastoma |
| VincristineAlso: OncovinVincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle). | Drug | Participants with Neuroblastoma |
| DoxorubicinAlso: AdriamycinDoxorubicin is an anthracycline antibiotic | Drug | Participants with Neuroblastoma |
| IfosfamideAlso: IsophosphamideIfosfamide is a structural analogue of cyclophosphamide | Drug | Participants with Neuroblastoma |
| EtoposideAlso: VePesid, Etopophos, VP-16Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each). | Drug | Participants with Neuroblastoma |
| CarboplatinAlso: ParaplatinCarboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials. | Drug | Participants with Neuroblastoma |
| IrinotecanAlso: CamptosarIrinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor | Drug | Participants with Neuroblastoma |
| TemozolomideAlso: TemodarTemozolomide is administered intravenously | Drug | Participants with Neuroblastoma |
| Radiation TherapyBetween first and second cycle of antibody | Radiation | Participants with Neuroblastoma |
Primary outcome
Evaluate participant response
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for High-risk Neuroblastoma
RecruitingPhase 2/3
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
High-Risk Neuroblastoma
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
RecruitingPhase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
Neuroblastoma
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiorella Iglasias Cardenas, MD, MS contact
Brian Kushner, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DANYELZA, Sargramostim and Cytoxan in people with High-risk Neuroblastoma and Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Kushner, MD (8336755491, kushnerb@MSKCC.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate participant response (time frame: After 2 cycles of mAb-based therapy (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.