Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
研究概览
简要总结
The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.
详细描述
Phase I trial. Single center study; patients will be referred to the study center from other institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine adjuvant.
Defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and transfected with mRNA encoding for hTERT, survivin and p53 if the tumour express p53. Frozen preparations of dendritic cells will be prepared using automated cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histological verified metastatic breast cancer or malignant melanoma, in progression
- •the patient must be habil
- •Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
- •Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
- •creatinin must be normal
- •Liverparametre <2.5 x normal. Bilirubin <30
- •Expected survival > 3 months
- •Informed consent
- •At least one measurable lesion according to RECIST criteria.
排除标准
- •Indication for chemotherapy
- •Other malignancies
- •Brain metastases
- •severe medical condition
- •Acute/chronic infection with ex. HIV, hepatitis, tuberculose
- •Severe allergy
- •Autoimmune disease
- •Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
- •Uncontrolled hypercalcemia.
结局指标
主要结局
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
时间窗: biweekly
次要结局
- to evaluate the duration of tumor and immunoresponse(3, 6, 9 months)
- to investigate the clinical tumor response and the duration(after 12 weeks)
- to evaluate immune response(at 8 and 12 weeks)
研究者
Inge Marie Svane
Professor, MD
Herlev Hospital