Study 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.
Eligible Conditions
- Malignant Glioma
- Brain Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 1 year
1 year
Optimal Timing of Surgical Procedure
30 days
Panitumumab
Day 30
Tumor to background ratio (TBR)
Up to 30 days
Number of grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably, or possibly related to the study treatment, graded according to Common Terminology Criteria for Adverse Effects (CTCAE) v. 4.0
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Cohort 2 -100mg panitumumab-IRDye800
1 of 3
Cohort 3 -100mg panitumumab-IRDye800
1 of 3
Cohort 1 -50mg panitumumab-IRDye800
1 of 3
Experimental Treatment
11 Total Participants · 3 Treatment Groups
Primary Treatment: Cohort 2 -100mg panitumumab-IRDye800 · No Placebo Group · Phase 1 & 2
Cohort 2 -100mg panitumumab-IRDye800Experimental Group · 4 Interventions: Panitumumab, Near-Infrared Fluorescence Imaging, Panitumumab-IRDye800, POINPOINT-IR9000 · Intervention Types: Biological, Procedure, Drug, Device
Cohort 3 -100mg panitumumab-IRDye800Experimental Group · 4 Interventions: Panitumumab, Near-Infrared Fluorescence Imaging, Panitumumab-IRDye800, POINPOINT-IR9000 · Intervention Types: Biological, Procedure, Drug, Device
Cohort 1 -50mg panitumumab-IRDye800Experimental Group · 4 Interventions: Panitumumab, Near-Infrared Fluorescence Imaging, Panitumumab-IRDye800, POINPOINT-IR9000 · Intervention Types: Biological, Procedure, Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
FDA approved
Panitumumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,441 Previous Clinical Trials
24,567,526 Total Patients Enrolled
Eben RosenthalLead Sponsor
8 Previous Clinical Trials
114 Total Patients Enrolled
Gordon LiPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments