Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Panitumumab-IRDye800
- device: Pinpoint-IR9000 endoscopic/handheld device
- device: Explorer Air camera
- device: PDE-NEO-II
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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
Ages Eligible for Study
6 Months - 25 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vyviann Ngo
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.