Not Yet RecruitingPhase 2

Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5

Israel10 participantsStarted 2026-05

Plain-language summary

This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.

Who can participate

Age range12 Months – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Newly diagnosed high risk neuroblastoma.
✓. BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days.
✓. Patients ≥ 547 days of age who were initially diagnosed with INRG L1 or L2 disease but progress to Stage M without chemotherapy
✓. Patients \< 547 days of age with INRG Stage M or MS disease and patients of any age with INRG L2 with MYCN amplification (v-myc avian myelocytomatosis viral related oncogene)
✓. Neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis, or
✓. demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
✓. MYCN testing will be done by FISH (Fluorescence In Situ Hybridization) assessment of the FFPE (Formalin-Fixed Paraffin-Embedded) material submitted from the tumor mass. \> 4-fold increase in MYCN signals as compared to reference signals will qualify as MYCN amplified.
✓. ONCOMINE testing will evaluate ALK (Anaplastic Lymphoma Kinase) mutation

What they're measuring

Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma

Timeframe: Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

Assess end-of-induction (EOI) response rates following concurrent Naxitamab and induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma.

Timeframe: Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

Assess end-of-induction (EOI) response rates following additional cycles of Irinotecan-Temodar-Naxitamab-GM-CSF in patients with high risk neuroblastoma and less than partial response (PR) after induction with COG type chemotherapy and Naxitamab

Timeframe: Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

Trial details

NCT IDNCT07537400

SponsorShaare Zedek Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Dr. Iris Fried

00972 508573151 irisf@szmc.org.il

View on ClinicalTrials.gov More High-Risk Neuroblastoma trials

Who can participate

Age range12 Months – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Newly diagnosed high risk neuroblastoma.
✓. BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days.
✓. Patients ≥ 547 days of age who were initially diagnosed with INRG L1 or L2 disease but progress to Stage M without chemotherapy
✓. Patients \< 547 days of age with INRG Stage M or MS disease and patients of any age with INRG L2 with MYCN amplification (v-myc avian myelocytomatosis viral related oncogene)
✓. Neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis, or
✓. demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
✓. MYCN testing will be done by FISH (Fluorescence In Situ Hybridization) assessment of the FFPE (Formalin-Fixed Paraffin-Embedded) material submitted from the tumor mass. \> 4-fold increase in MYCN signals as compared to reference signals will qualify as MYCN amplified.
✓. ONCOMINE testing will evaluate ALK (Anaplastic Lymphoma Kinase) mutation

What they're measuring

Evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma

Timeframe: Post 2nd course, and post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)

Assess end-of-induction (EOI) response rates following concurrent Naxitamab and induction chemotherapy in newly diagnosed patients with high-risk neuroblastoma.

Timeframe: Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)