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
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

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