Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Trial ID or NCT#

NCT03510208

Status

not recruiting iconNOT 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:
  1. - 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:
  1. - 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
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Investigator(s)

Gordon Li, MD
Gordon Li, MD
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology - Head & Neck Surgery (OHNS)
Reena Thomas, MD PhD
Reena Thomas, MD PhD
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Melanie Hayden Gephart
Melanie Hayden Gephart
Neurosurgeon
Professor of Neurosurgery and, by courtesy, of Neurology
Steven D. Chang, MD
Steven D. Chang, MD
Neurosurgeon, Aneurysm neurosurgeon, Cerebrovascular neurosurgeon, Pituitary tumors neurosurgeon, Stereotactic neurosurgeon
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
Chirag Patel, MD, PhD
Quan Zhou

Contact us to find out if this trial is right for you.

Contact

Monica Granucci
650-388-8906

View on ClinicalTrials.gov