Spots Global Cancer Trial Database for Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

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Trial Identification

Brief Title: Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma

Official Title: Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma

Study ID: NCT01883518

Conditions

Sarcoma

Neoplasms, Connective and Soft Tissue

Interventions

Autologous dendritic cell vaccine

Study Description

Brief Summary: The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas

Detailed Description: Vaccination is carried out on the planned days ± 3 days 1. All examinations must be performed before the vaccine is administered. * Full physical examination. * Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity. * Evaluation of concomitant therapy. * Assessment of vital signs. * Laboratory safety and immunological indicators * Assessment of adverse events, symptoms and syndromes of the disease. 2. Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use) 3. After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.