Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
- Conditions
- Children and young adults with advanced solid tumours: relapsed or metastatic sarcomas or central nervous system tumours.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003632-71-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method