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Recurrent OsteosarcomaPhase 2NCT02502786

Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

A Phase 2 study testing humanized anti-GD2 antibody and GM-CSF in people with Recurrent Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 months to 40 years
Conditions the study is for
Recurrent Osteosarcoma
What is being tested?
humanized anti-GD2 antibody and GM-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
3 sitesUnited States
Study dates
Jul 2015to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 months to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.)
  • Patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry.
  • Patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment.
  • Prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. More than one week should have elapsed since major surgery.
  • NOTE: Minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment)
  • Adequate hematopoietic function defined as:
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  • Absolute neutrophil count ≥ 500/ul
  • Absolute lymphocyte count ≥ 500/ul
  • Platelet count ≥ 50,000/ul (transfusion independent)
  • Adequate hepatic function as defined by:
  • Total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with Gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal).
  • AST (SGOT) of ≤ 3 times upper limit of normal
  • ALT (SGPT) of ≤ 3 times upper limit of normal
  • Adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal
  • Adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50%
  • Adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance
  • Adequate performance status as defined by ECOG score of ≤ 2 or Karnofsky/Lansky score ≥ 50%
  • Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with Hu3F8 is NOT allowed), but HAHA antibody titer must be negative
  • Women of child-bearing potential must be willing to practice an effective method of birth control while on treatment
  • Signed informed consent indicating awareness of the investigational nature of this program

Who cannot join

  • Patients with OS in first complete remission.
  • Presence of overt metastatic disease at any site.
  • Active life-threatening infection.
  • Pregnant women or women who are breast-feeding.
  • Inability to comply with protocol requirements.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • MD ANDERSON CANCER CENTER (Data Collection Only)

    Houston, Texas, 77030

  • Children's Hospital of Los Angeles (Data Collection Only)

    Los Angeles, California, 90027

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

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.

Being tested
humanized anti-GD2 antibody, GM-CSF
Keywords
Humanized Monoclonal Antibody 3F8 (Hu3F8), Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), 15-096
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • humanized anti-GD2 antibodyBiological

    Also called hu3F8

  • GM-CSFDrug

Study groups in NCT02502786
Study groupRoleWhat they receive
humanized anti-GD2 antibody, hu3F8, when combined with GM-CSFExperimentalOne 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.
Receives: Biological: humanized anti-GD2 antibody; Drug: GM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. event free survival (EFS)

    EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.

    Measured: 12 months

Secondary outcomes (1)

  1. time to recurrence

    Time to recurrence will be estimated using Kaplan-Meier methods. Very few patients are expected to die without relapse (<5%). Recurrence is defined as the radiographic presence of any new lesion that is not attributable to differences in scanning techniques, change in imaging modality or findings thought to represent something other than osteosarcoma, or if a biopsy is performed which shows osteosarcoma.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502786
Sponsor's protocol ID
15-096
Status last verified
Aug 2026
First submitted
16 Jul 2015
Last updated
5 Aug 2026
Results posted
No

Publications

  • Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

    PubMed 31401903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing humanized anti-GD2 antibody and GM-CSF in people with Recurrent Osteosarcoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

event free survival (EFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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