This phase I/II trial tests the safety and side effects of panitumumab IRDye800 and how well it works in combination with near infrared imaging in detecting tumor tissue in pediatric patients undergoing surgery to remove a brain tumor. Current standard of care for brain tumors is complete surgical resection. Achieving a complete surgical resection depends on successfully removing all tumor tissue and avoiding normal brain tissue. However, existing tumor imaging may limit the ability of the surgeon to remove all the tumor tissue. Panitumumab IRDye800 is composed of panitumumab, a monoclonal antibody, and IRDye800, a near-infrared fluorescent dye. Panitumumab-IRDye800 targets and binds to the protein, EGFR, found on tumor cells which may make them more visible using a special camera that emits a special light, near-infrared (NIR) light, during surgery. Panitumumab IRDye800 may be safe, tolerable and when used with NIR imaging may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04085887.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Laura M. Prolo
Phone: 650-497-8775
PRIMARY OBJECTIVE:
I. Assess safety of panitumumab IRDye800 in the pediatric patients with brain tumors.
SECONDARY OBJECTIVES:
I. Identify the optimal dose of panitumumab IRDye800.
II. Determine efficacy of panitumumab IRDye800 to detect microscopic disease and residual tumor during surgical resection of pediatric malignant brain tumors.
EXPLORATORY OBJECTIVES:
I. Assess if preoperative magnetic resonance imaging (MRI) permeability findings can be correlated to intraoperative and ex vivo fluorescence imaging data.
II. Assess the correlation between aminolevulinic acid (5-ALA) and panitumumab-IRDye800 in the subset of patients that has received both 5-ALA and panitumumab-IRDye800.
OUTLINE:
Patients receive panitumumab IRDye800 intravenously (IV) over 60 minutes on day 0 and after 1-5 days undergo surgical excision per standard of care. Patients also undergo NIR imaging during and post surgery. Additionally, patients undergo MRI at screening and blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 15 and 30 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorLaura M. Prolo
