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Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Not Recruiting
Trial ID: NCT03510208
Purpose
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.
Official Title
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
Stanford Investigator(s)
Gordon Li, MD
Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)
Reena Thomas, MD PhD
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Melanie Hayden Gephart
Professor of Neurosurgery and, by courtesy, of Neurology
Steven D. Chang, MD
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
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
Intervention(s):
procedure: Near-Infrared Fluorescence Imaging
biological: Panitumumab
drug: Panitumumab-IRDye800
device: POINPOINT-IR9000
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Monica Granucci
650-388-8906