Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: Cetuximab
  • Drug: Cetuximab-IRDye 800CW
  • Procedure: Tumor resection

Phase:

Phase 1/Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting