Osteosarcoma Response to Dinutiximab and Sargramostim – Phase II

Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab) in Combination with GM-CSF (Sargramostim) in Patients with Recurrent Osteosarcoma

Protocol Description

This multicenter research study, explores how well dinutuximab works when given with sargramostim (GM-CSF) in treating patients with osteosarcoma that has come back after treatment. Dinutuximab is a type of drug called a monoclonal antibody. It is designed to recognize a specific target on the surface of cancer cells. It then attaches to the cancer cells and kills them, without harming normal cells. Sargramostim may help the body increase the production of white blood cells, which help to fight off infections. Giving sargramostim with dinutuximab may help the dinutuximab work better and kill more cancer cells.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to pediatric patients of both genders, up to 29 years of age, who have osteosarcoma with at least one episode of disease recurrence in the lungs, and which was surgically removed at least 4 weeks prior to study enrollment.
Males and Females: Up to 29 years old


Participants will receive the study drugs in 28-day cycles. Sargramostim will be given on days 1 through 14 via injection, and dinutuximab via intravenous infusion on days 4 and 5 of each cycle. After 2 treatment cycles, tests and imaging will be done to see if the tumor has come back. If not, patients may remain enrolled in the study for up to 5 cycles.
Visits: Same as standard chemotherapy for this condition
Duration: About 5 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AOST1421)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean Tersak, MD