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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Trial ID or NCT#

NCT03510208

Status

RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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
- 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
- White blood cell count > 3000/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
- Serum creatinine > 1.5 times upper reference range
- 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

View All Criteria

Investigator(s)

Gordon Li, MD

Neurosurgeon

Associate Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology-Head and Neck Surgery at the Stanford University Medical Center

Eben Rosenthal

Otolaryngologist

Professor of Otolaryngology-Head and Neck Surgery and of Radiology (Molecular Imaging Program at Stanford)

Chirag Patel, MD, PhD

Neuro-oncologist

Clinical Instructor, Neurology & Neurological Sciences

Reena Thomas

Neuro-oncologist

Clinical Assistant Professor, Neurology & Neurological Sciences

Melanie G Hayden Gephart

Steven D. Chang, MD

Neurosurgeon, Aneurysm neurosurgeon, Cerebrovascular neurosurgeon, Pituitary tumors neurosurgeon, Stereotactic neurosurgeon, Neuro-oncologist

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

CONTACT

Stefania Ursu Chirita
650.723.1423

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View on ClinicalTrials.gov

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