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

NCT ID: NCT02502786

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Recurrent Osteosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF

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.

Group Type: EXPERIMENTAL

humanized anti-GD2 antibody

Intervention Type: BIOLOGICAL

GM-CSF

Intervention Type: DRUG

Interventions

humanized anti-GD2 antibody

Intervention Type: BIOLOGICAL

GM-CSF

Intervention Type: DRUG

Other Intervention Names

hu3F8

Eligibility Criteria

Inclusion Criteria

• 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:

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 13 Months
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Y-mAbs Therapeutics

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Filemon Dela Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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

Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MD ANDERSON CANCER CENTER (Data Collection Only)

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31401903 (View on PubMed)

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-096

Identifier Type: -

Identifier Source: org_study_id