Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults

Study Overview
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Brief Summary
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Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.

Detailed Description
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Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.

Official Title
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Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults

Conditions
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Sarcoma, Central Nervous System Tumor

Intervention / Treatment
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* Biological: dendritic cells
* Procedure: Surgery as needed by the patient´s tumor and stage
* Drug: Chemotherapy as needed by the patient´s tumor and stage
* Radiation: Radiation therapy as needed by the patient´s tumor and stage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor From 3 to 40 years Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal. Exclusion Criteria: Toxicity or liver, medullar, renal insufficiency that advise against participation Pregnant or breast feeding women Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma Immunosuppressive treatment Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccines with autologous dendritic cells<br>Vaccines with autologous dendritic cells | Biological: dendritic cells<br>* vaccines with dendritic cells pulsed with tumor lysate<br>Procedure: Surgery as needed by the patient´s tumor and stage<br> <br> Drug: Chemotherapy as needed by the patient´s tumor and stage<br> <br> Radiation: Radiation therapy as needed by the patient´s tumor and stage<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of adverse events detected in the follow up as a measure of safety and tolerability |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy |  | 36 months | 
| Humoral and cellular immune response as a measure of the immunogenicity of the vaccine. |  | 2 weeks to 24 months | 
| Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires. |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy