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

NCT02502786 | Active Not Recruiting Phase 2

• 1 other identifier: 15-096
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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

Keywords

Humanized Monoclonal Antibody 3F8 (Hu3F8); Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF); 15-096

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (1)

• time to recurrence

  12 months

Study Arms (1)

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

EXPERIMENTAL

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.

Biological: humanized anti-GD2 antibody; Drug: GM-CSF

Interventions

humanized anti-GD2 antibody BIOLOGICAL

Also known as: hu3F8

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

GM-CSF DRUG

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

Eligibility Criteria

• Age: 13 Months - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Children's Hospital Los Angeles: collaborator
• M.D. Anderson Cancer Center: collaborator
• Y-mAbs Therapeutics: collaborator

Study Sites (3)

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

Los Angeles, California, 90027, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD ANDERSON CANCER CENTER (Data Collection Only)

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 31401903 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Osteosarcoma

Interventions

humanized 3F8 anti-GD2 monoclonal antibody; naxitamab; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Filemon Dela Cruz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (3)