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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
All examinations must be performed before the vaccine is administered.
Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use)
After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous dendritic cell vaccine | Experimental | Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cell vaccine | Biological | Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 month |
| Median overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuriy Komarov, PhD | N. N. Petrov Research Institute of oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N. N. Petrov Research Institute of oncology | Saint Petersburg | 197758 | Russia |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005354 | Fibrosarcoma |
| D018319 | Neurofibrosarcoma |
| D051642 | Histiocytoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| D002813 | Chondrosarcoma |
| D013584 | Sarcoma, Synovial |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D009217 | Myosarcoma |
| D012208 | Rhabdomyosarcoma |
| D018234 | Sarcoma, Alveolar Soft Part |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
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| ID | Term |
|---|---|
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
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|
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 |
| 6 month |
| Objective response rate | The percentage of patients whose cancer shrinks or disappears after treatment. | 6 mounth |
| Assess biological response of tumors | Сhanging level of T lymphocytes subpopulation in peripheral blood | 6 mounth |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018205 | Neoplasms, Adipose Tissue |