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

This is an interventional treatment trial for Sarcoma Read More

Inclusion Criteria for part 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;
• Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if it depends solely on orthopedic problems)
• Estimated life expectancy > 3 months;
• Adequate bone marrow functions:
• Signed informed consent;
• Negative serum or urine pregnancy test within 48 hours from collection of peripheral blood or from lympho cyto apheresis (if post-pubertal female patients);
• Archived histological tumour sample available

Inclusion Criteria for part 2

• Patients with histologically documented unresectable sarcomas which progressed after a first or further line treatments for relapsing disease
• Measurable disease (bone lesions are included);
• Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if its depend solely on orthopedic problems)
• Estimated life expectancy > 3 months;
• Adequate bone marrow, hepatic and renal functionality
• Signed informed consent;
• Archived histological tumour sample available;
• Patients should have a venous central access;
• 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

• History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection;
• 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;
• 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

• Patients with Ewing/Primitive Neuroectodermal Tumor Sarcoma, Rhabdomyosarcoma as well as other rapidly growing sarcomas are not to be included in the study;
• Presence of Central Nervous System metastases and/or meningeal neoplastic involvement;
• Patients with seizure disorders;
• Severe renal, vascular, cardiac, hepatic, lung disorders;
• 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
• Patients with a non-optimal ex-vivo expansion of autologous CIK cells during Part 1 (< 0.5 x 107/kg CIK cells);
• History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection;
• Presence of bleeding disorders;
• Patients undergoing renal dialysis;
• Presence of uncontrolled diabetes
• Patients unable to swallow oral medications;
• Patients receiving concomitant steroid or immunotherapy (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency).
• Anticancer chemotherapy or experimental drugs or immunotherapy or radiotherapy 2 weeks before entering the study;
• Anticancer chemotherapy or experimental drugs or immunotherapy or radiotherapy on target lesions 2 weeks before entering the study;
• Prior exposure to CIK cells;
• Major surgery 4 weeks before entering the study;
• Minor surgery 1 week before entering the study;
• Patients with allergic reactions or hypersensibility to excipient
• Pregnant or breast-feeding patients;
• 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.