Pilot Study: Detection of Colorectal Metastatic Liver Disease Preoperatively Using 124I-Labeled M5A Monoclonal Antibody to Carcinoembryonic Antigen (CEA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A
研究概览
简要总结
This phase I trial studies how well an imaging agent called I-124 M5A works in detecting CEA-positive colorectal cancer that has spread to the liver. I-124 M5A is a monoclonal antibody, called M5A, linked to a radioactive substance called I-124. M5A binds to CEA-positive cancer cells and may, through imaging scans, be able to detect liver metastases by picking up signals from I-124.
详细描述
PRIMARY OBJECTIVES:
I. To determine the ability of iodine I 124 monoclonal antibody M5A (124I-labeled M5A monoclonal antibody [MAb]) to localize to CEA positive gastrointestinal (GI) metastases primarily focused on the liver.
SECONDARY OBJECTIVES:
I. To determine the safety and pharmacokinetics of administration of 124I-labeled M5A MAb.
II. To correlate the radiographic positron emission tomography (PET) images to the liver metastases pathology.
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
- •Patients must have histologically confirmed metastatic colorectal cancer with liver metastases. NOTE: We are not requiring proof of CEA positive disease because > 95% of colorectal cancers are CEA positive
- •The effects of 124I-M5A on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- •Patients must have at least 2 known sites of metastatic liver disease. Patients should have at least one resectable liver metastasis as assessed by hepatobiliary surgical oncology
- •The results of the imaging scans that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
- •Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody
排除标准
- •Patients should not have any uncontrolled illness including ongoing or active infection
- •Patients who have allergy to iodine or iodine contrast agents are not eligible for this protocol
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to 124I-M5A
- •Patients must not have received prior chemotherapy or radiation for >= 2 weeks before study enrollment
- •Pregnant women are excluded from this study because 124I-M5A is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 124I-M5A, breastfeeding should be discontinued if the mother is treated with 124I-M5A
- •Patients with single (= 1) liver metastasis are not eligible for this protocol
- •Any patient who has had exposure to mouse, chimeric (human/mouse) or humanized immunoglobulin and has antibody to the M5A
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Tumor targeting pharmacokinetic parameters of iodine I 124 monoclonal antibody M5A
时间窗: Days 0, 2, and 6 drawn at approximately 1 hour, 2 hour and 3-4 hours post-end of infusion
Will be observed using standard imaging scans obtained pre-operatively and to assess if the antibody detects new liver metastases. Serum concentration data will be tabulated and descriptive statistics computed.
Percent of known liver lesions per standard staging scans identified on iodine I-124 (I-124) M5A imaging
时间窗: Up to 1 year
次要结局
- Percent of patients with suspicious liver lesions identified on I-124 M5A but were not identified on standard imaging(Up to 1 year)
- Surgical results (when available per standard of care surgery/pathology) on lesions negative on I-124 M5A but positive on standard scans(Up to 1 year)
- I-124 identification of extra-hepatic lesions (both previously noted or new)(Up to 1 year)
- Incidence of adverse events(Up to 14 days post infusion)
- Surgical pathology results (when available) on lesions positive on I-124 M5A but negative on standard imaging(Up to 1 year)