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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2023
  • participants needed
    46
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 4 October 2022
platelet count
monoclonal antibodies
shortening fraction
cytotoxic chemotherapy
neutrophil count
blood transfusion
hu3f8

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.

Details
Condition Recurrent Osteosarcoma
Treatment GM-CSF, humanized anti-GD2 antibody
Clinical Study IdentifierNCT02502786
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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