Bone and soft tissue sarcoma
Conditions
Interventions
Case series:none
Sponsors
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age below 70 at the time of screening, both male and female; 2) confirmed by histology and pathology of bone and soft tissue sarcomas, MRI/CT imaging has diffuse thickening, meningeal linear or nodular enhancement meninges, or water on the brain and meninges metastasis and spinal canal lesions, with or without typical clinical manifestations, or cerebrospinal fluid cytology positive, namely the definite diagnosis of bone and soft tissue sarcomas meningeal metastasis. ; 3) willing to participate in this study, the subjects/legal representative written informed consent; 4) in the eastern United States tumor group (ECOG) physical status score of 0 to 2 points. 5) has a good level of organ function, Bone marrow function to meet: neutrophil count (ANC) acuity 1.5 x 10^9 / L; Platelet count (PLT) =100×10^9/L; Hemoglobin (Hb) =9g/dL; Renal function, serum creatinine (Cr) 1.5 times the upper limit of normal or creatinine clearance or greater or less 50 ml/min; Liver function: the total bilirubin < 1.5 x ULN (for gilbert syndrome were recorded, < 2.0 x ULN or for indirect bilirubin levels rising prompt extrahepatic source of subjects, < 3.0 x ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN (if liver metastasis occurs, = 5 x ULN); Coagulant function, prothrombin time (PT) or part of a clotting time live enzymes (PTT) < 1.5 x normal limit (ULN), or international standardization ratio (INR) < 1.5 or within the target range (if preventive anticoagulation); 6) female patients need a pregnancy test negative; 7) for three years without family planning, contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) There are contraindications of intrathecal chemotherapy; Received brain or meningeal metastases within 6 months. ; 2) the subjects are using immunosuppressant can be absorbed, or body, or local hormone therapy to achieve immunosuppression (> 10 mg/day dose effect of hormones such as prednisone or other), and 2 weeks before into the group continues to use; 3) there is no active participants autoimmune disease or a history of autoimmune disease; 4) subjects had active TB; 5) subjects had hepatitis c or HIV infection, or syphilis infection; 6) there are no severe and/or failed to control the disease, including: blood pressure control is not ideal (systolic blood pressure 150 mmHg, or diastolic blood pressure, 100 mmHg or higher) patients. Have grade I or higher myocardial ischemia or myocardial infarction, arrhythmias (including QTc =480ms), and grade =2 congestive heart failure (NYHA); 7) judging by the researchers, the participants there are other factors may result in midway termination, such as other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or test data and the collection of the sample.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central system focal control rate,overall survival; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Affiliated Sixth People's Hospital, Shanghai Jiaotong University
Outcome results
None listed