Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.

Inclusion Criteria for part 1 1. Patients with histologically documented unresectable sarcomas which progressed after first or further line treatments for relapsing disease who could be enrolled in Part 2 of study immediately or after a new line of treatment; 2. Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if it depends solely on orthopedic problems) 3. Estimated life expectancy \> 3 months; 4. Adequate bone marrow functions: 5. Signed informed consent; 6. Negative serum or urine pregnancy test within 48 hours from collection of peripheral blood or from lympho cyto apheresis (if post-pubertal female patients); 7. Archived histological tumour sample available Inclusion Criteria for part 2 1. Patients with histologically documented unresectable sarcomas which progressed after a first or further line treatments for relapsing disease 2. Measurable disease (bone lesions are included); 3. Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if its depend solely on orthopedic problems) 4. Estimated life expectancy \> 3 months; 5. Adequate bone marrow, hepatic and renal functionality 6. Signed informed consent; 7. Archived histological tumour sample available; 8. Patients should have a venous central access; 9. Pregnancy test should be negative 48 hours before treatment for post-pubertal women patients. All post-pubertal patients are to take adequate anti-contraceptive measures during treatment and until 8 weeks after the last dose of treatment. Exclusion Criteria for part 1 1. History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection; 2. Patients receiving chemotherapy and/or immunotherapy and/or anti-tumour agents and/or radiotherapy on more than 10% of bone marrow area two weeks before peripheral blood collection or lymphocytapheresis; 3. Patients with neuro-psychiatric disorders or social or geographic problems that would prohibit the understanding or rendering informed consent and compliance with the requirements of this protocol are excluded. Exclusion Criteria for part 2 1. Patients with Ewing/Primitive Neuroectodermal Tumor Sarcoma, Rhabdomyosarcoma as well as other rapidly growing sarcomas are not to be included in the study; 2. Presence of Central Nervous System metastases and/or meningeal neoplastic involvement; 3. Patients with seizure disorders; 4. Severe renal, vascular, cardiac, hepatic, lung disorders; 5. Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, heart failure ≥ grade 2, a recent heart attack within 6 months, uncontrolled heart non arrhythmia uncontrolled metabolic disorders, cirrhosis, uncontrolled hypertension 6. Patients with a non-optimal ex-vivo expansion of autologous CIK cells during Part 1 (\< 0.5 x 107/kg CIK cells); 7. History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection; 8. Presence of bleeding disorders; 9. Patients undergoing renal dialysis; 10. Presence of uncontrolled diabetes 11. Patients unable to swallow oral medications; 12. Patients receiving concomitant steroid or immunotherapy (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). 13. Anticancer chemotherapy or experimental drugs or immunotherapy or radiotherapy 2 weeks before entering the study; 14. Anticancer chemotherapy or experimental drugs or immunotherapy or radiotherapy on target lesions 2 weeks before entering the study; 15. Prior exposure to CIK cells; 16. Major surgery 4 weeks before entering the study; 17. Minor surgery 1 week before entering the study; 18. Patients with allergic reactions or hypersensibility to excipient 19. Pregnant or breast-feeding patients; 20. Patients with neuro-psychiatric disorders or social or geographic problems that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol are excluded.