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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

ConditionHigh-Risk Neuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorShaare Zedek Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age - 12 months to 21 years at protocol enrollment

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

Disqualifiers

Subjects who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy.

This will not restrict the emergency regimen at initial diagnosis.

Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.

Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.

Trial design

Design model

Single group

Treatments tested in this trial

  • Naxitamab

    Drug

    Naxitamab and GM-CSF administered with COG type induction chemotherapy.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Naxitamab and GM-CSFExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

This measure will be assessed by evaluating treatment side effects.

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

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

This measure will be assessed using the 1993 International Neuroblastoma Response Criteria (INRC) criteria.

Time frame
Post 5th course of chemoimmunotherapy (therapy lasts approximately 4 and a half months)
3

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

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

Secondary outcomes

1

Determine event-free survival (EFS) in newly diagnosed high-risk neuroblastoma patients

Time frame
From enrollment until completion of follow-up, 5 years from diagnosis
2

Metastatic complete response after cycle 2 and at end of induction.

To be assessed using one of the following: MIBG - Metaiodobenzylguanidin; CT - Computed Tomography; MRI - Magnetic Resonance Imaging; PET-DOPA - Fluorine-18 Fluorodopa Positron Emission Tomography.

Time frame
Post 2nd course, and post 5th course of induction therapy (therapy lasts approximately 4 and a half months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shaare Zedek Medical Center

Lead sponsor

Y-mAbs Therapeutics

Collaborator

Source ClinicalTrials.gov
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