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

Recurrent Osteosarcoma Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02502786
• Other study ID #: 15-096
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Months to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteosarcoma
• Recurrence
• Recurrent Osteosarcoma

Intervention

Biological:
• humanized anti-GD2 antibody

Drug:
• GM-CSF

Locations

Country	Name	City	State
United States	MD ANDERSON CANCER CENTER (Data Collection Only)	Houston	Texas
United States	Children's Hospital of Los Angeles (Data Collection Only)	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Children's Hospital Los Angeles, M.D. Anderson Cancer Center, Y-mAbs Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to recurrence	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.	12 months

External Links

•   Memorial Sloan Kettering Cancer Center