Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 25
Healthy Volunteers: f
View:
• Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
• Subjects must be eligible for resection as determined by the operating surgeon.
• Planned standard of care surgery
• Subject age 6 months to 25 years
• Life expectancy of more than 12 weeks
Locations
United States
California
Stanford Cancer Center
RECRUITING
Stanford
Contact Information
Primary
Nancy Sweeters
nks2016@stanford.edu
650-721-4074
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 12
Treatments
Experimental: Cohort 1-0.006 Panitumumab-IRDye800
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
Experimental: Cohort 2-0.25 Panitumumab-IRDye800
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
Experimental: Cohort 3-0.50 Panitumumab-IRDye800
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
Experimental: Cohort 4-1.0 Panitumumab-IRDye800
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
Authors
Related Therapeutic Areas
Sponsors
Leads: Stanford University