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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Toxicities (related adverse events)
研究概览
简要总结
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 2-0.25 Panitumumab-IRDye800
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
干预措施: Explorer Air camera (Device)
Cohort 1-0.006 Panitumumab-IRDye800
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
干预措施: PDE-NEO-II (Device)
Cohort 2-0.25 Panitumumab-IRDye800
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
干预措施: Pinpoint-IR9000 endoscopic/handheld device (Device)
Cohort 2-0.25 Panitumumab-IRDye800
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
干预措施: PDE-NEO-II (Device)
Cohort 3-0.50 Panitumumab-IRDye800
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
干预措施: Pinpoint-IR9000 endoscopic/handheld device (Device)
Cohort 3-0.50 Panitumumab-IRDye800
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
干预措施: Explorer Air camera (Device)
Cohort 3-0.50 Panitumumab-IRDye800
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
干预措施: PDE-NEO-II (Device)
Cohort 1-0.006 Panitumumab-IRDye800
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 2-0.25 Panitumumab-IRDye800
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 4-1.0 Panitumumab-IRDye800
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 3-0.50 Panitumumab-IRDye800
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 1-0.006 Panitumumab-IRDye800
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
干预措施: Pinpoint-IR9000 endoscopic/handheld device (Device)
Cohort 1-0.006 Panitumumab-IRDye800
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
干预措施: Explorer Air camera (Device)
Cohort 4-1.0 Panitumumab-IRDye800
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
干预措施: Pinpoint-IR9000 endoscopic/handheld device (Device)
Cohort 4-1.0 Panitumumab-IRDye800
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
干预措施: Explorer Air camera (Device)
Cohort 4-1.0 Panitumumab-IRDye800
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
干预措施: PDE-NEO-II (Device)
结局指标
主要结局
Toxicities (related adverse events)
时间窗: 30 days
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
次要结局
- Panitumumab-IRDye800 Fluorescence Intensity(5 days)
- Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level(7 days)