Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - Any
Updated:3/10/2019
Start Date:April 3, 2018
End Date:December 2023
Contact:Joris Wilms
Email:clinicaltrials@ymabs.com
Phone:+4570261414

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A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory
disease or incomplete response to salvage treatment in bone and/or bone marrow will be
treated for up to 93 weeks with naxitamab and granulocyte-macrophage colony stimulating
factor (GM-CSF). Patients will be followed for up to five years after first dose.

Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Each patient will receive treatment for up to 93 weeks following the first Naxitamab
administration and remain in the trial for 101 weeks. After the end of trial visit, each
patient will enter a long-term follow-up where they will be monitored for up to 5 years after
first treatment cycle.

Each investigational cycle is started with 5 days, days -4 to 0, of Granulocyte-Macrophage
Colony Stimulating Factor (GM-CSF) administered at 250 µg/m2/day in advance of the start of
Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5.
As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5,
totalling 9 mg/kg per cycle.

Treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial
response followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are
repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of
the investigator. End of treatment will take place around 8 weeks after the last cycle and
thereafter long-term follow-up will continue.

Inclusion Criteria:

- Diagnosis of neuroblastoma as defined per International Neuroblastoma Response
Criteria

- High-risk neuroblastoma patients with either primary refractory disease or incomplete
response to salvage treatment (in both cases including stable disease, minor response
and partial response) evaluable in bone and/or bone marrow.

- Life expectancy ≥ 6 months

Exclusion Criteria:

- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3
weeks before 1st dose of GM-CSF

- Evaluable neuroblastoma outside bone and bone marrow

- Existing major organ dysfunction > Grade 2, with the exception of hearing loss,
hematological status, kidney and liver function

- Active life-threatening infection
We found this trial at
6
sites
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Houston, Texas 77030
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Phone: 317-948-8540
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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555 University Avenue
Toronto, M5G 1X8
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Toronto,
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