Overview
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.
Description
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.
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 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