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Recruiting
NCT04085887
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
Conditions: Brain Tumor
Sex: All
Ages: 6 Months – 25 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 12
Sponsor: Stanford University
Location: Stanford Cancer Center Stanford California
Summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
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
Source: ClinicalTrials.gov (NCT04085887). StuddyBuddy aggregates publicly available trial information.