Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

• Status: Suspended
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Collaborator: National Institutes of Health (NIH)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Panitumumab

Criteria

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