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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
N. N. Petrov Research Institute of oncology
Saint Petersburg, Russia
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas
Time frame: 6 month
Median progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works
Time frame: 6 month
Median overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works
Time frame: 6 month
Objective response rate
The percentage of patients whose cancer shrinks or disappears after treatment.
Time frame: 6 mounth
Assess biological response of tumors
Сhanging level of T lymphocytes subpopulation in peripheral blood
Time frame: 6 mounth
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