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Panitumumab-IRDye800 in Diagnosing Participants with Malignant Glioma Undergoing Surgery
Trial Status: active
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.
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 felt 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 440 ms in males or greater than 460 ms in females)
Thyroid-stimulating hormone (TSH) >= 13 micro international units/mL
Magnesium, potassium and calcium lower than the normal institutional values
Other lab values that in the opinion of the physician 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
Additional locations may be listed on ClinicalTrials.gov for NCT03510208.
I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma.
SECONDARY OBJECTIVES:
I. Determine the efficacy of panitumumab-IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue.
II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio.
III. Determine the optimal timing of the surgical procedure to maximize the tumor-to-background ratio.
EXPLORATORY OBJECTIVES:
I. Assess if preoperative magnetic resonance imaging (MRI) permeability findings can be correlated to intraoperative and ex vivo fluorescence imaging data.
II. Assess the correlation between 5-aminolevulinic acid (5-ALA) and panitumumab-IRDye800 in the subset of patients that has received both 5-ALA and panitumumab-IRDye800.
OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study. Participants are assigned to 1 of 2 groups.
GROUP A (Cohorts 1a, 2a, & 3): Participants receive panitumumab intravenously (IV) over 60 minutes on day 0, and following a 15-minute observation period, receive panitumumab-IRDye800 IV over 60 minutes. Participants then undergo near-infrared fluorescence (NIR) imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.
GROUP B (Cohorts 1b and 2b): Participants receive panitumumab-IRDye800 IV over 60 minutes on day 0. Participants then undergo NIR imaging as in Group A.
After completion of study treatment, participants are followed up on day 15 and then again on day 30.
Trial PhasePhase I/II
Trial Typediagnostic
Lead OrganizationStanford Cancer Institute Palo Alto
