Trial Search Results

Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery

This pilot phase I/II trial studies 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Biological: Cetuximab
  • Drug: Cetuximab-IRDye 800CW
  • Procedure: Conventional Surgery
  • Other: Laboratory Biomarker Analysis


Phase 1/Phase 2


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 felt to be candidates for resection

   - Subjects must be eligible for resection as determined by the operating surgeon

   - Planned standard of care surgery

   - Life expectancy of more than 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/mm^3

   - 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

   - 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 cetuximab or other monoclonal antibody therapies

   - Pregnant or breastfeeding

   - Subjects who have a serious reaction with the test/loading cetuximab dose for which
   they were not able to receive the full dose

   - Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440
   ms in males or greater than 450 ms in females)

   - 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 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting