NCT00162929已完成1 期
A Phase I Study Investigating Multiple Injections of Autologous CD34+ Derived Dendritic Cells Transduced With an Adenovirus Expressing Rat Her-2/Neu in Patients With Metastatic or Locally Recurrent Breast Cancer
Ontario Clinical Oncology Group (OCOG)0 个研究点目标入组 5 人开始时间: 2005年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 主要终点
- toxicity
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Metastatic or locally recurrent breast cancer
- •18 years of age or older
- •Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
- •One of the following:
- •currently receiving hormonal therapy or are candidates for such, or
- •being considered for trastuzumab, or
- •cancer has progressed on trastuzumab.
排除标准
- •Pregnant or lactating women.
- •Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
- •Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
- •Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
- •Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
- •Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
- •CD4 cells < 0.5 ×10^9/L
- •Patients with documented brain metastases.
- •Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
- •Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
- •Eastern Cooperative Oncology Group (ECOG) performance status of >
- •Patients with a life expectancy of less than 6 months.
- •Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
- •Failure to give written informed consent.
- •Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.
结局指标
主要结局
toxicity
时间窗: weeks 4, 6, 7, 10, 14, 18, 22, 26
次要结局
- tumour response(Weeks 6, 18)
研究者
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