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

NCT02502786

Description:

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.

Related Conditions:
  • Osteosarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 15-096
  • NCT ID: NCT02502786

Conditions

  • Recurrent Osteosarcoma

Interventions

DrugSynonymsArms
humanized anti-GD2 antibodyhu3F8humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF
GM-CSFhumanized anti-GD2 antibody, hu3F8, when combined with GM-CSF

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
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.
  • humanized anti-GD2 antibody
  • GM-CSF

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 MSKCC must have pathology
             confirmed by MSKCC 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 older than 1 year of age and less than or equal to 40 years of age.

          -  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.

          -  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 of ≤ 3 times upper limit of normal

               -  ALT 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 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 ≤1300 Elisa units/mL

          -  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.
      
Maximum Eligible Age:40 Years
Minimum Eligible Age:13 Months
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:event free survival (EFS)
Time Frame:12 months
Safety Issue:
Description:EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.

Secondary Outcome Measures

Measure:time to recurrence
Time Frame:12 months
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

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

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