Clinical Trial Details
Braintumor Website

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NCT03510208 : Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
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

- 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

- 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
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