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Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
Not Recruiting
Trial ID: NCT02855086
Purpose
This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how
well it works in detecting tumors in patients with malignant glioma who are undergoing
surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells
when a special camera is used.
Official Title
Open-Label Study Evaluating Cetuximab-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)
Eligibility
INCLUSION CRITERIA
- Suspected brain tumors to undergo removal (surgical resection) as standard of care, as
assessed by the operating surgeon
- Life expectancy of > 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/mm³
- Magnesium, potassium and calcium > the lower limit of normal per institution normal
lab values
- Thyroid-stimulating hormone (TSH) < 13 micro international units/mL
EXCLUSION CRITERIA
- Received an investigational drug within 30 days prior to first dose of cetuximab
IRDye800
- Within 6 months prior to enrollment, myocardial infarction (MI); cerebrovascular
accident (CVA); uncontrolled congestive heart failure (CHF); significant liver
disease; or unstable angina
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440
ms in males or greater than 450 ms in females)
- Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone,
sotalol) antiarrhythmic agents
- Pregnant or breastfeeding
Intervention(s):
biological: Cetuximab
drug: Cetuximab-IRDye 800CW
procedure: Tumor resection
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061