Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Malignant Glioma Clinical Trial

Official title: Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

Status Recruiting

Clinical Trial Summary

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma.

SECONDARY OBJECTIVES:

I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue.

II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio.

III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio.

OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma
• Malignant Brain Neoplasm
• Malignant Glioma
• Neoplasms

• NCT number: NCT03510208
• Study type: Interventional
• Source: Stanford University
• Contact: Monica Granucci
• Phone: 650-388-8906
• Email: migranucci@stanford.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 16, 2018
• Completion date: December 31, 2024