Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

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. Participants are assigned to 1 of 2 groups.

GROUP A (Cohorts 1a, 2a, & 3): Participants receive panitumumab intravenously (IV) over 60
minutes on day 0, and following a 15-minute observation period, receive panitumumab-IRDye800
IV over 60 minutes. Participants then undergo near-infrared fluorescence (NIR) imaging during
standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

GROUP B (Cohorts 1b and 2b): Participants receive panitumumab-IRDye800 IV over 60 minutes on
day 0. Participants then undergo NIR imaging as in Group A.

After completion of study treatment, participants are followed up on day 15 and then again on
day 30.

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

- Planned standard of care surgery

- Life expectancy of more than 12 weeks

- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group
(ECOG)/Zubrod level 1

- Hemoglobin ≥ 9 gm/dL

- Platelet count ≥ 100,000/mm^3

- White blood cell count > 3000/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

- 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