Sarcoma, Central Nervous System Tumor
Conditions
Keywords
dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy
Brief summary
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
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.
Interventions
BIOLOGICALdendritic cells
vaccines with dendritic cells pulsed with tumor lysate
PROCEDURESurgery as needed by the patient´s tumor and stage
DRUGChemotherapy as needed by the patient´s tumor and stage
RADIATIONRadiation therapy as needed by the patient´s tumor and stage
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and type of adverse events detected in the follow up as a measure of safety and tolerability | 24 months |
Secondary
| Measure | 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 |
Countries
Spain
Outcome results
None listed