Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Summary

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

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

Conditions2

Locations1 site

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