Recruiting
Phase 2

Reduced Chemotherapy & mAb

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06528496

Conditions

High-risk Neuroblastoma

Neuroblastoma

Childhood Neuroblastoma

Eligibility Criteria

Sex: All

Age: 1 - 19

Healthy Volunteers: Not accepted

Interventions

DANYELZA

Sargramostim

Cytoxan

Topotecan

Vincristine

Study Details

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.

Conditions

High-risk Neuroblastoma

Neuroblastoma

Childhood Neuroblastoma

Study ID

NCT06528496

Start date

Jul 22, 2024

Status verified date

Aug, 2026

Completion date

Jul 22, 2029

Anticipated

Primary completion date

Jul 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 19

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Neuroblastoma

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

Interventions

DANYELZA

DANYELZA is a humanized monoclonal antibody of the IgG1 subclass

Sargramostim

Yeast derived recombinant human Sargramostim (GM-CSF)

Cytoxan

Cyclophosphamide is an alkylating agent related to nitrogen mustard

Topotecan

Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.

Vincristine

Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).

Doxorubicin

Doxorubicin is an anthracycline antibiotic

Ifosfamide

Ifosfamide is a structural analogue of cyclophosphamide

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).

Carboplatin

Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.

Irinotecan

Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor

Temozolomide

Temozolomide is administered intravenously

Radiation Therapy

Between first and second cycle of antibody

Primary outcome measure

  • Evaluate participant response [ Time Frame: After 2 cycles of mAb-based therapy (each cycle is 21 days) ]

Central Contacts and Locations

Central contacts

Brian Kushner, MD

8336755491kushnerb@MSKCC.ORG

Fiorella Iglasias Cardenas, MD, MS

iglesiaf@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Brian Kushner, MD

212-639-6793

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • High-risk neuroblastoma
  • neuroblastoma
  • childhood neuroblastoma
  • N10
  • Memorial Sloan Kettering Cancer Center
  • 24-144

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-28.