Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03510208 : Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
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

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03510208      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740