Panitumumab‑IRDye800 imaging to help surgeons find pediatric brain tumor tissue during neurosurgery
Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
This will test whether a fluorescent drug called panitumumab‑IRDye800 helps surgeons see tumor tissue and tiny residual disease in children and young adults having brain tumor surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 6 Months to 25 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | Panitumumab, chemotherapy, radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04085887 on ClinicalTrials.gov |
What this trial studies
This Phase 1–2 trial gives a single infusion of panitumumab‑IRDye800 to pediatric patients 1 to 5 days before planned surgical resection of a suspected brain tumor, with dose escalation to identify an optimal dose. Intraoperative near‑infrared imaging with handheld and wide‑field devices is used during surgery to try to highlight tumor tissue, and resected specimens are imaged on the back table and with close‑field devices without destroying tissue. The study follows participants for 30 days after infusion with scheduled visits on the day of surgery, Day 15, and Day 30 to monitor safety and adverse events. Secondary aims include determining whether the agent improves detection of microscopic disease and residual tumor during resection.
Who should consider this trial
Good fit: Children and young adults aged 6 months to 25 years with a suspected brain tumor who are planned for surgical resection, eligible for surgery per the operating surgeon, and with life expectancy greater than 12 weeks are the intended participants.
Not a fit: Patients who are not having tumor resection, who are pregnant or breastfeeding, who have a history of severe infusion reactions to monoclonal antibodies, recent investigational drug exposure, significant recent cardiac/liver disease, or QTc prolongation on ECG may not be eligible or receive direct benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the imaging agent could help surgeons better identify tumor margins and microscopic residual disease during surgery, which may improve completeness of resection and surgical decision making.
How similar studies have performed: Antibody‑based fluorescent tracers (including EGFR‑targeting agents) have shown promising safety and tumor‑highlighting results in adult and early‑phase studies for other cancers, but application in pediatric brain tumors is novel and data are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California
- Stanford Cancer Center — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Laura Prolo, MD — Stanford University
- Study coordinator: Nancy Sweeters
- Email: nks2016@stanford.edu
- Phone: 650-721-4074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.