Status:
RECRUITING
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
Lead Sponsor:
Stanford University
Conditions:
Brain Tumor
Eligibility:
All Genders
6-25 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Detailed Description
Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors. Secondary Objective: * To identify the optimal dose of panit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
- Magnesium, potassium and calcium \< the lower limit of normal per institution normal lab values
- Serum creatinine \> 1.5 times upper reference range
- Other lab values that in the opinion of the primary surgeon would prevent surgical resection
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Subjects not deemed to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04085887
Start Date
January 1 2026
End Date
December 1 2028
Last Update
November 18 2025
Active Locations (1)
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1
Stanford Cancer Center
Stanford, California, United States, 94304