Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Launched by STANFORD UNIVERSITY · Sep 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a special dye called panitumumab-IRDye800 to help doctors find and remove brain tumors in children and young adults during surgery. The main goal is to see if this dye is safe for pediatric patients who need surgery to remove suspected tumors. The trial is not yet recruiting participants, but it will include children and young adults aged 6 months to 25 years who are scheduled for surgery to remove a tumor as part of their regular treatment.

To be eligible for this trial, participants must have a suspected brain tumor and be able to have surgery to remove it, as determined by their surgeon. They should also have a life expectancy of more than 12 weeks. However, some individuals may not qualify if they have recently taken certain medications, have specific health conditions, or if the tumor's location makes surgery too risky. Participants in the trial can expect to undergo the standard care for their surgery, with the potential addition of this new dye to help the surgeons see the tumor better. This study aims to improve the safety and effectiveness of brain tumor surgeries in young patients.

Gender

ALL

Eligibility 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 felt to be candidates for resection.
• • Subjects must be eligible for resection as determined by the operating surgeon.
• • Planned standard of care surgery
• • Subject age 6 months to 25 years
• • Life expectancy of more than 12 weeks
• 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 QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)
• • 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