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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003632-71 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccines with autologous dendritic cells | Experimental | Vaccines with autologous dendritic cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dendritic cells | Biological | vaccines with dendritic cells pulsed with tumor lysate |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and type of adverse events detected in the follow up as a measure of safety and tolerability | 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Patiño-García, PhD | CUN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Navarra | Pamplona | Navarre | 31008 | Spain |
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| Surgery as needed by the patient´s tumor and stage | Procedure |
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| Chemotherapy as needed by the patient´s tumor and stage | Drug |
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| Radiation therapy as needed by the patient´s tumor and stage | Radiation |
|
| Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires. | 36 months |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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