Gene Therapy Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- biological: Cetuximab
- drug: Cetuximab-IRDye 800CW
- procedure: Tumor resection
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