Pilot Trial of PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Safety as Measured by the Number of Participants Who Experienced Toxicity
研究概览
简要总结
The purpose of the first group (Group 1) was to find the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long it stayed in the blood, and to see how well it was tolerated. From what the investigators have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood draws. This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered patient at MSKCC
- •Age ≥18 years
- •Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer HER2 positive status by FISH or IHC as currently being implemented for patients with esophagogastric cancer. HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (≥2.0)
- •Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (CT, MRI, FDG PET or bone scan). Patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present.
- •Karnofsky Performance Score ≥ 60
- •Ability to understand and willingness to sign informed consent
- •Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
- •Life expectancy of at least three (3) months.
- •Willingness to use birth control while on study.
- •The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results.
- •Concurrent therapy will be allowed.
排除标准
- •Inability to lie still for the duration of the scanning procedure.
- •Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
- •Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab.
- •HIV positive or active hepatitis.
- •History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entry
- •Hematologic
- •Platelets <50K/mcL
- •ANC <1.0 K/mcL
- •Hepatic laboratory values
- •Bilirubin >2 x ULN (institutional upper limits of normal), with exception of patients with Gilberts disease. AST/ALT >2.5 x ULN (institutional upper limits of normal); >5 x ULN if liver metastasis
- •Renal laboratory values
- •Estimated GFR (eGFR) < 30mL/min/1.73m2
结局指标
主要结局
Safety as Measured by the Number of Participants Who Experienced Toxicity
时间窗: 2 years
Participants will be evaluated for toxicity using CTCAE v4.0
Feasibility of Antibody-imaging
时间窗: 2 years
Antibody imaging is considered feasible if 70% of the patients are antibody-imaging positive. Antibody imaging will be considered feasible if 7 or more of the 10 patients in the first cohort are antibody-imaging-positive. We will also require that none of these patients experience severe toxicity attributable to the initial antibody.
次要结局
- Biologic Half-time(Up to 580 hours)