EUCTR2013-003632-71-ESActive, not recruitingPhase 1
Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
Clínica Universidad de Navarra/Universidad de Navarra0 sites10 target enrollmentStarted: November 12, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Investigators
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