Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Not Recruiting

Trial ID: NCT04085887

Purpose

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Official Title

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

Stanford Investigator(s)

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

Intervention(s):

drug: Panitumumab-IRDye800

device: Pinpoint-IR9000 endoscopic/handheld device

device: Explorer Air camera

device: PDE-NEO-II

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Vyviann Ngo