This pilot early phase I clinical trial studies sargramostim in increasing infiltration of immune cells in younger patients with ependymoma that has not been completely removed by surgery or that has come back (recurrent). Sargramostim helps the body produce infection fighting white blood cells, including a specific white blood cell called macrophage. Raising the granulocyte count may prevent infection and raising the macrophage count may help fight the tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04408092.
PRIMARY OBJECTIVES:
I. To determine if sargramostim (granulocyte macrophage colony stimulation factor [GM-CSF]) increases the macrophage tumor infiltration of children with high risk ependymoma compared to the infiltration at their initial surgery and to historical controls.
SECONDARY OBJECTIVES:
I. Correlation of GM-CSF treatment and microglia/macrophage infiltration/activity with progression and time to progression in children with ependymoma.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) once daily (QD) or intravenously (IV) over 2 hours beginning 5 days after each course of chemotherapy until blood counts recover.
ARM II: Patients receive sargramostim SC QD or IV over 2 hours for 5 days before surgery.
After completion of study treatment, patients are followed up to 5 years.
Lead OrganizationChildren's Hospital Colorado
Principal InvestigatorNicholas Kenneth Foreman