ISRCTN81721411已完成2 期
A Phase II, open-label study to evaluate the safety, tolerability, and pharmacokinetic profile of Proxinium™ in patients with recurrent squamous cell carcinoma of the head and neck who have received at least one prior anti-cancer treatment regimen for recurrent disease
Viventia Biotech Inc (Canada)0 个研究点目标入组 18 人开始时间: 2006年8月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The patient must have histologically confirmed SCCHN
- •2. The patient must have immunohistochemically confirmed Epithelial Cell Adhesion Molecule (Ep-CAM)?positive SCCHN
- •3. The patient must have received therapy for their primary disease (i.e., SCCHN) consisting of radiotherapy with or without surgery and with or without chemotherapy
- •4. Patients must have progressed on or after receiving at least one prior anti-cancer treatment regimen containing one or more anti-cancer agents (e.g., chemotherapy, biologic therapy, or photodynamic therapy) for their recurrent disease
- •5. The patient must have fully recovered or reached a stable state of symptomatology from any previous treatment-related toxicity
- •6. The patient must have at least one accessible target tumor without direct carotid artery involvement (ie, a distance of less than 5 mm between a tumor and carotid) and must be likely to retain study drug
排除标准
- •1. The patient has known brain tumor or brain metastases
- •2. The patient has nasopharyngeal SCCHN
- •3. The patient has concurrent or documented history of any one of the following:
- •a. Human Immunodeficiency Virus (HIV)
- •b. Hepatitis C virus
- •c. Hepatitis B surface antigen
- •4. The patient has uncontrolled bleeding from any target tumor(s) that are being considered for Proxinium™ treatment
- •5. The patient has a history of tumor hemorrhage that has required medical intervention (other than direct compression)
- •6. The patient is a candidate for surgical tumor resection of their target tumor(s)
- •7. The patient is pregnant or lactating
- •8.The patient has clinically significant renal or hepatic disease
- •9. The patient requires regular use of aspirin, full-dose warfarin, or heparin. Use of low-dose agents to maintain patency of vascular catheters is allowed
研究者
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