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临床试验/EUCTR2013-003632-71-ES
EUCTR2013-003632-71-ES进行中(未招募)1 期

Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults

Clínica Universidad de Navarra/Universidad de Navarra0 个研究点目标入组 10 人开始时间: 2013年11月12日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • All patients must fulfil the following inclusion criteria in order to be selected and participate in the study:
  • 1.Informed consent signed by the patient or his/her legal representative if minor
  • 2.Diagnosis of metastatic or relapsed sarcoma or high grade central nervous system tumor
  • 3.Age between 3 and 40 years-old
  • 4.The patient will receive the standard treatment for his disease, including surgery, In patients with CNS tumors residual tumor volume after surgery should be minimal
  • 5.The patient must be able to fulfil all the clinical trial assay requirements, according to the researcher´s criteria.
  • All patients must fulfil the following inclusion criteria in order to receive the experimental treatment:
  • 6.Tumor availability and possibility to obtain dendritic cells (apheresis)
  • 7.Development of enough quantity of mature dendritic cells to initiate treatment
  • 8.Negative pregnancy test
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 10
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients who present any of the following characteristics will not be admitted in the clinical trial:
  • 1.Liver, renal or bone marrow toxicity that advise against the patients´s participation, according to the researcher´s criteria
  • 2.Pregnant women or in breastfeeding period
  • 3.Diagnosis of any other cancer, except basal cell carcinoma, treated cervical carcinoma or any other tumor type in remission for a period longer than three years.
  • 4.Patients who need immunosuppressive treatment
  • 5.Active infection by HIV, HBV, HCV or syphilis
  • 6.Complete contraindication to receive the remaining standard treatment against the tumour (chemo and/or radiotherapy and surgery).

研究者

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