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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502786
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : December 23, 2022
Sponsor:
Collaborators:
Children's Hospital Los Angeles
M.D. Anderson Cancer Center
Y-mAbs Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Osteosarcoma Biological: humanized anti-GD2 antibody Drug: GM-CSF Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Biological: humanized anti-GD2 antibody
Other Name: hu3F8

Drug: GM-CSF


Outcome Measures
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Primary Outcome Measures :
  1. event free survival (EFS) [ Time Frame: 12 months ]
    EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.


Secondary Outcome Measures :
  1. time to recurrence [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   13 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502786


Contacts
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Contact: Filemon Dela Cruz, MD 646-888-2275
Contact: Michael Kinnaman, MD 212-639-5952

Locations
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United States, California
Children's Hospital of Los Angeles (Data Collection Only) Recruiting
Los Angeles, California, United States, 90027
Contact: Fariba Navid, MD    323-660-2450      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Filemon Dela Cruz, MD    646-888-2275      
Contact: Michael Kinnaman, MD    212-639-5952      
Principal Investigator: Filemon Dela Cruz, MD         
United States, Texas
MD ANDERSON CANCER CENTER (Data Collection Only) Recruiting
Houston, Texas, United States, 77030
Contact: Douglas Harrison, MD    713-456-5995      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Children's Hospital Los Angeles
M.D. Anderson Cancer Center
Y-mAbs Therapeutics
Investigators
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Principal Investigator: Filemon Dela Cruz, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02502786    
Other Study ID Numbers: 15-096
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Humanized Monoclonal Antibody 3F8 (Hu3F8)
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
15-096
Additional relevant MeSH terms:
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Osteosarcoma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma
Antibodies
Immunologic Factors
Physiological Effects of Drugs