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

Investigating Treatment Effects of an Investigational Antibody in High-Risk Neuroblastoma

Recruiting
1 years - 100 years
All
Phase N/A
1 Location

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.
Participants will be reimbursed for their participation as needed. Please discuss with study team.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neuroblastoma
  • Age: 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

Updated on 19 Feb 2024. Study ID: 1711085080 (PHO-YMABS-201)

This study investigates the treatment effects of an investigational antibody in children and adults with high-risk neuroblastoma. Neuroblastoma is a type of cancer that forms in certain types of nerve tissue, and high-risk means that the cancer is more likely to come back or spread. The study focuses on patients whose disease did not respond completely to previous treatments or who have cancer in their bones or bone marrow.

Participants will receive treatment for up to 93 weeks with an investigational antibody and a substance that helps stimulate white blood cell growth. The investigational antibody is a humanized monoclonal antibody that targets a specific protein on cancer cells. Participants will be monitored for up to five years after their first dose to assess the treatment's effects.

  • Who can participate: Individuals diagnosed with high-risk neuroblastoma, either primary refractory or secondary refractory, are eligible. Participants should have a life expectancy of at least 6 months. Participants who have received recent systemic anti-cancer therapy, have evaluable neuroblastoma outside bone and bone marrow, or have major organ dysfunction are not eligible.
  • Study details: Participants will receive an investigational antibody and a growth factor to stimulate white blood cells. The investigational antibody is designed to target cancer cells. An inactive substance that looks like the investigational medicine but does not contain any medicine may be used as a placebo. Participants will be monitored for treatment effects.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here