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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003632-71-ES

Enrollment

Registered

2013-11-12

Start date

2014-07-14

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children and young adults with advanced solid tumours: relapsed or metastatic sarcomas or central nervous system tumours.

Interventions

Product Name: Células dendríticas autólogas Pharmaceutical Form: Suspension for injection INN or Proposed INN: Células dendríticas autólogas Other descr

Eligibility

Sex/Gender

All

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the safety of the proposed treatment in terms of: - Effects attributable to the generation and administration of dendritic cells - Adverse effects during treatment - Autoimmunity ; Secondary Objective: As secondary objectives we will analyze the effect of treatment with dendritic cells upon clinical parameters of efficacy - Reduction of tumoral lesions - Time to progression - Event-free survival - Overall survival - Quality of life according to EORTC tests Immunogenicity of the vaccine (biological efficacy) by in vitro analysis of the immune response: - Humoral response against autologue tumor cells, tumor lysates - Cellular response (prolifearation, cytokine production, specific cytotoxicity) - Phenotypic analysis of the different populations in peripheral blood Finally, we will characterize the cellular product and correlate the findings with clinical efficacy ;Primary end point(s): Primary end points are safety of treatment and clinical efficacy (decrease of the size of the lesion, event-free survival and overall survival of vaccinated patients);Timepoint(s) of evaluation of this end point: Primary end points will be evaluated during treatment and afterwards, following the completion of vaccination. Regular follow-up of patients will continue over a period of three years. After this time, the patient will be still followed but outside the context of this clinical trial.	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the safety of the proposed treatment in terms of: - Effects attributable to the generation and administration of dendritic cells - Adverse effects during treatment - Autoimmunity ; Secondary Objective: As secondary objectives we will analyze the effect of treatment with dendritic cells upon clinical parameters of efficacy - Reduction of tumoral lesions - Time to progression - Event-free survival - Overall survival - Quality of life according to EORTC tests Immunogenicity of the vaccine (biological efficacy) by in vitro analysis of the immune response: - Humoral response against autologue tumor cells, tumor lysates - Cellular response (prolifearation, cytokine production, specific cytotoxicity) - Phenotypic analysis of the different populations in peripheral blood Finally, we will characterize the cellular product and correlate the findings with clinical efficacy ;Primary end point(s): Primary end points are safety of treatment and clinical efficacy (decrease of the size of the lesion, event-free survival and overall survival of vaccinated patients);Timepoint(s) of evaluation of this end point: Primary end points will be evaluated during treatment and afterwards, following the completion of vaccination. Regular follow-up of patients will continue over a period of three years. After this time, the patient will be still followed but outside the context of this clinical trial.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are studies of specific immune response induced by the vaccine (determination of antibodies and cellular immune response).;Timepoint(s) of evaluation of this end point: The immune response studies will be performed two weeks after the last vaccine for each patient. Therefore, the time point for this end point will be two months after the last vaccine for each patient.	—

Measure

Time frame

Secondary end point(s): Secondary end points are studies of specific immune response induced by the vaccine (determination of antibodies and cellular immune response).;Timepoint(s) of evaluation of this end point: The immune response studies will be performed two weeks after the last vaccine for each patient. Therefore, the time point for this end point will be two months after the last vaccine for each patient.

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Countries

Spain

Contacts

Public ContactUCICEC

Clínica Universidad de Navarra

ucicec@unav.es34948255 4001142

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026