Clinical Trial Finder

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 assessed to be candidates for resection.

• - Subjects must be eligible for resection as determined by the operating surgeon.

• - Platelet count ≥ 75,000/mm^3.

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 corrected QT (QTc) prolongation on pre-treatment electrocardiography (ECG) (greater than 440ms in males or greater than 460ms in females) - Thyroid-stimulating hormone (TSH) ≥ 13 micro international units/mL.

• - Magnesium, potassium and calcium < the lower limit of normal per institution normal lab values.

• - 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

PRIMARY OBJECTIVES:

• I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma.

SECONDARY OBJECTIVES:

• I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue.

• II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio.

• III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio.

OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.

Arms

Experimental: Cohort 1 -50mg panitumumab-IRDye800

A panitumumab-IRDye800 dose of 50mg (Cohort 1) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

Experimental: Cohort 2 -100mg panitumumab-IRDye800

A panitumumab-IRDye800 dose of 100mg (Cohort 2) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

Experimental: Cohort 3 -100mg panitumumab-IRDye800

Cohort 3 dose will be determined based on Cohort 1 and Cohort 2, with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery

Interventions

Procedure: - Near-Infrared Fluorescence Imaging

Undergo NIR imaging

Biological: - Panitumumab

Given IV

Drug: - Panitumumab-IRDye800

Given IV

Device: - POINPOINT-IR9000

Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite ("back table").