NCT01445054终止早期 1 期
A Phase 0 Trial of (111)Indium CHX-A DTPA Trastuzumab Imaging in Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC
研究概览
简要总结
Background:
- Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu.
- An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell.
- Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin.
Objectives:
-To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not.
Eligibility:
-Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study.
Design:
- Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status.
- Patients have a physical examination and review of medical records.
- Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin.
- Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin.
- Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
详细描述
Background:
- Trastuzumab (Herceptin ), targets HER2 (aka: neu, ErbB2, c-erb-B2) on the surface of cancer cells and is used in the treatment of breast cancers that overexpress HER2/Neu (Erb2). It has also been demonstrated that other malignancies express HER2/Neu (Erb2).
- Radiolabeling trastuzumab could allow human biodistribution studies, noninvasive assessment of HER2/Neu (Erb2) expression, identification of HER2/Neu (Erb2) positive metastases, monitoring of treatment response and establishment of dosimetry for future radioimmunotherapy.
- We have developed a chelated form of trastuzumab, CHX-A DTPA-trastuzumab, that can bind a number of radioisotopes including (111)In, (212), (213)Bi, (212)Pb (86), (90)Y and (177)Lu which have alpha, beta and gamma emissions for imaging and therapy.
- We believe that the agent will be safe based on the low dose of trastuzumab (up to a maximum of 200 mcg of protein or less than1% of the typical loading dose of trastuzumab in a 70 Kg human) and the low dose of radioactivity (5mCi).
- Whereas trastuzumab therapy is generally only useful in tumors that highly express HER2/Neu (Erb2), (111)In-CHX-A DTPA trastuzumab (henceforth (111)Indium-trastuzumab ) will image tumors that are not only highly expressing HER2/Neu (Erb2) but also tumors that are poorly expressing HER2/Neu (Erb2) as documented by preclinical data.
Objectives:
-The primary objective is to compare uptake of 111Indium trastuzumab with HER2/Neu (Erb2) status of the tumor as determined by IHC
Eligibility:
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1-Arm 1
Experimental
Subjects with primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
干预措施: 111Indium CHX-A (Drug)
结局指标
主要结局
Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC
时间窗: 5 days after intervention
Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC
次要结局
- Optimal timing of 111Indium-CHX-A DTPA trastuzumab imaging as a function of HER2/ Neu(ErbB2) status.(completion of study)
- Pharmacokinetic serum clearance of 111Indium-CHXA DTPA trastuzumab(24 hours after intervention)
- To evaluate the change in 111Indium-CHX-A DTPA trastuzumab uptake in tumors following treatment with a HER2 targeted therapy(completion of study)
- Safety of 111Indium-trastuzumab.(30 days after intervention)
- Biodistribution of the agent in normal organs(completion of study)
研究者
研究点 (1)
Loading locations...
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