Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Recruiting

I'm Interested

Trial ID: NCT03510208

Purpose

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.

Official Title

Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-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)

Reena Thomas, MD PhD
Reena Thomas, MD PhD

Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery

Melanie Hayden Gephart
Melanie Hayden Gephart

Professor of Neurosurgery and, by courtesy, of Neurology

Steven D. Chang, MD
Steven D. Chang, MD

Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology

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

Intervention(s):

procedure: Near-Infrared Fluorescence Imaging

biological: Panitumumab

drug: Panitumumab-IRDye800

device: POINPOINT-IR9000

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Monica Granucci
650-388-8906

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