A Phase 3 Trial of Antibody hu3F8 and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease
T
Terry Vik, MD
Primary Investigator
Recruiting
1-100 years
All
Phase
N/A
2 Locations
Brief description of study
The purpose of this research trial is to find out about the treatment effects of an antibody called humanized 3F8 (hu3F8).
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Neuroblastoma,Osteomedullary Disease,Osteomedullary Disease
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Age: Between 1 Years - 100 Years
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Gender: All
Inclusion Criteria
Diagnosis of neuroblastoma (NB)
High-risk neuroblastoma with either primary refractory or secondary refractory osteomedullary disease (persistent neuroblastoma at osteomedullary sites after prior treatment)
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
Additional Information:Diagnosis of neuroblastoma (NB)
High-risk neuroblastoma with either primary refractory or secondary refractory osteomedullary disease (persistent neuroblastoma at osteomedullary sites after prior treatment)
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
Participants will be reimbursed for their participation as needed. Please discuss with study team.
Updated on
01 Aug 2024.
Study ID: 1711085080 (PHO-YMABS-201)
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