Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Panitumumab

Criteria

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