NCT02855086

Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery

Open-Label Study Evaluating Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Eben Rosenthal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.

Detailed description

This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts. COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. COHORT II: Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0. All patients undergo standard of care surgical resection of tumor on days 2-5. After completion of study, patients are followed up at days 10 and 30. PRIMARY OBJECTIVE: Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio. SECONDARY OBJECTIVE: Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.

Conditions

• Brain Neoplasm
• Malignant Glioma

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab	Administered intravenously (IV)
DRUG	Cetuximab-IRDye 800CW	Administered intravenously (IV)
PROCEDURE	Tumor resection	Standard of care treatment

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-08
• Completion: 2016-11-22
• First posted: 2016-08-04
• Last updated: 2020-03-31
• Results posted: 2018-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study