Gene Therapy Clinical Trials
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Near-Infrared Fluorescence Imaging
- biological: Panitumumab
- drug: Panitumumab-IRDye800
- device: POINPOINT-IR9000
Eligibility
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 assessed to be candidates for resection
- Subjects must be eligible for resection as determined by the operating surgeon
- Platelet count ≥ 75,000/mm^3
Exclusion Criteria:
- Received an investigational drug within 30 days prior to first dose of
panitumumab-IRDye800
- 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 monoclonal antibody therapies
- Pregnant or breastfeeding
- Evidence of corrected QT (QTc) prolongation on pre-treatment electrocardiography (ECG)
(greater than 440ms in males or greater than 460ms in females)
- Thyroid-stimulating hormone (TSH) ≥ 13 micro international units/mL
- Magnesium, potassium and calcium < the lower limit of normal per institution normal
lab values
- Other 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 with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- 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
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Monica Granucci
650-388-8906
I'm interested