Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Trial ID or NCT#
The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.
Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
- - 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
- - 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
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