Trial Summary
What is the purpose of this trial?The purpose of this study is to find out what effect an antibody called Humanized 3F8 (Hu3F8) and a drug called GM-CSF have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.
Eligibility Criteria
This trial is for people aged 1-40 who have recurrent osteosarcoma and are in at least their second complete remission. They must have normal organ function, no overt metastases, not be pregnant or breastfeeding, and can't have had the study drug before. Participants need to agree to use birth control and should not have a life-threatening infection.Inclusion Criteria
My heart is strong enough, with good pumping ability.
I've had treatments with anti-GD2 antibodies but not Hu3F8, and I don't have HAHA antibodies.
I don't have trouble breathing at rest and can exercise without issues.
My cancer is in its second or later complete remission.
My kidney function is within the normal range.
I can take care of myself but might not be able to do heavy physical work.
I am between 1 and 40 years old.
My liver tests are within the required range.
My osteosarcoma has come back, confirmed by tissue analysis.
My blood cell counts are within the required range and I don't need transfusions.
Exclusion Criteria
My cancer has spread to other parts of my body.
My cancer is in its first complete remission.
I do not have a severe infection that is putting my life at risk.
Treatment Details
The trial tests Humanized Monoclonal Antibody 3F8 (Hu3F8) combined with GM-CSF on patients with recurrent osteosarcoma. It aims to see if this combination helps keep patients in remission longer without the cancer coming back.
1Treatment groups
Experimental Treatment
Group I: humanized anti-GD2 antibody, hu3F8, when combined with GM-CSFExperimental Treatment2 Interventions
One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at \~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol. If elevations of amylase and/or lipase (\>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF.
GM-CSF is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Leukine for:
- Neutropenia
- Bone Marrow Transplantation
- Leukemia
- Lymphoma
- HIV Infection
🇪🇺 Approved in European Union as Sargramostim for:
- Neutropenia
- Bone Marrow Transplantation
- Leukemia
- Lymphoma
🇨🇦 Approved in Canada as Leukine for:
- Neutropenia
- Bone Marrow Transplantation
- Leukemia
- Lymphoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Children's Hospital of Los Angeles (Data Collection Only)Los Angeles, CA
MD ANDERSON CANCER CENTER (Data Collection Only)Houston, TX
Memorial Sloan Kettering Cancer CenterNew York, NY
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
Children's Hospital Los AngelesCollaborator
M.D. Anderson Cancer CenterCollaborator
Y-mAbs TherapeuticsIndustry Sponsor