Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery

Launched by STANFORD UNIVERSITY · Apr 17, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a special dye called panitumumab-IRDye800, which helps doctors see brain tumors more clearly during surgery. The dye attaches to cancerous cells, making them stand out on a special camera used in the operating room. This could help surgeons better differentiate between tumor cells and normal brain tissue, potentially allowing them to find smaller tumors that might be missed with current imaging techniques.

To participate in this trial, you need to be between the ages of 65 and 74 and have a suspected brain tumor that requires surgical removal. You should also have a certain level of platelets in your blood. However, if you've had recent heart problems, are pregnant or breastfeeding, or have certain other health issues, you may not be eligible. If you join the trial, you’ll receive this dye before your surgery, and your doctors will monitor how well it works and if there are any side effects. This research aims to improve how brain tumors are diagnosed and treated, ultimately benefiting patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1) One of the following:
• • 1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
• • 2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma
• • 2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and/or participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.
• • 3) Participant age ≥ 18 years.
• • 4) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Exclusion Criteria:
• • 1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.
• • 2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.
• • 3. History of infusion reactions to monoclonal antibody therapies
• • 4. Pregnant or breastfeeding.
• • 5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
• 6. Any of the following lab values:
• • 1. Platelet count \< 75,000/mm3
• • 2. TSH ≥ 13 micro International Units/mL.
• • 3. Magnesium, potassium, or calcium \< each respective upper limit of normal
• • 4. Serum creatinine \> 1.5 times upper limit of normal
• • 7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• • 8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• • 9. Participants not deemed by PI 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.