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
Overview
The purpose of this research trial is to find out about the treatment effects of an antibody called humanized 3F8 (hu3F8).
Description
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
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Neuroblastoma,Osteomedullary Disease,Osteomedullary Disease
-
Age: Between 1 Years - 100 Years
-
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
15 May 2024.
Study ID: 1711085080 (PHO-YMABS-201)
Connect with a study center near you
,
You have contacted , on
Your message has been sent to the study team at ,
A copy of the message has been sent to your email
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact