autologous dendritic cell vaccine in patients with soft tissue sarcoma

Conditions: Sarcoma; Neoplasms, Connective and Soft Tissue

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

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.

Eligibility criteria:
inclusion criteria: * age of 18 or older * ecog performance score 0 or 1 * histologically proven soft tissue sarcoma * unresectable or metastatic soft tissue sarcoma * ability to give written informed consent * objective measured and measurable tumor lesions * the failure of standard therapy * adequate amount of material for genetic research * no active or chronic infection with hiv, hepatitis b or hepatitis c * men/women of childbearing potential must use adequate contraception * hematology, liver function and renal function lab tests within required parameters exclusion criteria: * untreated or uncontrolled brain metastases. * history of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma. * autoimmune disease (vitiligo is not a basis for exclusion). * serious uncontrolled medical disorder or active infection that would impede treatment. * underlying medical or psychiatric condition that would cause administration vaccine * any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine * concomitant therapy with il-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed). * dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements. * pregnant or breastfeeding women. * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.

Keywords: fibrosarcoma neurofibrosarcoma histiocytoma histiocytoma, malignant fibrous chondrosarcoma synovial sarcoma leiomyosarcoma liposarcoma myosarcoma rhabdomyosarcoma sarcoma, alveolar soft part ny-eso-1 mage mage a3 vaccine immunotherapy