Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Sponsor: Stanford University

Sponsor score: 40

ClinicalTrials ID:NCT04085887

This study evaluates the safety and optimal dosing of panitumumab-IRDye800 in pediatric patients undergoing brain tumor resection. Eligible participants are aged 6 months to 25 years with a life expectancy over 12 weeks. The intervention involves IV administration of panitumumab-IRDye800 and intraoperative imaging using various devices to detect residual tumor tissue. Participants are monitored for 30 days post-infusion.

Patient Parameters

Parameter	Options

Program Overview

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Description

Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Secondary Objective:

To identify the optimal dose of panitumumab IRDye800 in pediatric patients
To determine efficacy of panitumumab IRDye800 to detect microscopic disease and residual tumor during surgical resection of pediatric malignant brain tumors

Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.

Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.

Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.

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

Locations

FACILITY	ZIP	CITY	STATE
Stanford Cancer Center	94304	Stanford	California

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