metastatic tumor of bone
Conditions
Interventions
experimental group:Zoledronic acid + thalidomide
Sponsors
Shanghai Sixth People's hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. through histology or cytology, the diagnosis of prostate, breast, or non small cell lung cancer, with imaging diagnosis of bone metastasis or bone pain, fracture and other symptoms, and meet the following conditions; 1) no radiotherapy was performed 3 months before treatment, and no radiotherapy was expected during the study period (6 months). 2) Hb decreased II level (Hb = 60 ~ 90 g/L, Annex 1); 2. aged 18~70 years, men and women; 3. physical status score, KPS score > 60 points (Annex 3); 4. the expected survival time more than 6 months; 5. coagulation function is normal, or mild abnormality (CTC AE 4.03 I level), recovered after treatment. 6. 4 weeks before the experiment, no class EPO or other erythrocyte drugs were used, and no transfusion history (whole blood or concentrated red blood cells) was available within 4 weeks. 7. childbearing age women had no reproductive plan and contraceptive measures voluntarily during the 12 months after the study and after the last medication; 8. patients understand the purpose and steps of the trial, voluntarily participate in the trial, and sign written informed consent; 9. patients are willing and able to follow the research visit plan and other program requirements. 10. partial remission (PR).
Exclusion criteria
Exclusion criteria: 1. patients who had participated in Thalidomide Tablets clinical trials; 2. because of other diseases, we must take bone marrow suppression drugs; 3. female patients were positive for pregnancy test; 4. patients with renal anemia; 5. patients with a history of chronic blood disease; 6. other chronic bleeding patients; 7. those who had neurotoxicity in the past; 8. allergic to thalidomide, lenalidomide or dexamethasone; 9. with pleural effusion, ascites and ascites reached above 800ml or pleural effusion / ascites, leading to respiratory syndrome (NCI CTC AE4.03 grade 2 or grade 2 dyspnea). Grade [2 dyspnea refers to breathing in a small amount of activities, affecting instrumental activities of daily living]; 10. in 5 years, there were or at the same time with other malignant tumors. The cured cervical carcinoma in situ, the skin cancer of the non melanoma and the superficial bladder tumor except the [Ta (non invasive tumor), the Tis (in situ cancer) and the T1 (tumor infiltrating basement membrane)]; 11. because any previous treatment resulted in a higher response rate than the CTC AE (4.03) grade 1, no remission toxicity, excluding hair loss; 12. there are many factors that affect oral drugs, such as dysphagia and intestinal obstruction; 13. imaging has confirmed that patients with brain metastases or patients with brain metastases who have symptoms or symptoms for less than 2 months; 14. there are any patients with severe and / or not controlled diseases, including: 1) blood pressure control is not ideal (more than 150 mmHg systolic blood pressure, diastolic blood pressure greater than 100 mmHg) patients; 2) suffering from myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QTc > 480ms) and more than 2 levels of congestive heart failure (New York Heart Association (NYHA)); 3) severe liver and renal dysfunction (AST, ALT>5 times the upper limit of normal value, total bilirubin >1.5 times the upper limit of normal value, SCr >1.5 times the upper limit of normal value). 15. 28 days before grouping, major surgical treatment, open biopsy or obvious traumatic injury were accepted. 16. imaging shows that the tumor invades the important blood vessels or the researchers judge the patients who are likely to attack the important blood vessels and cause fatal hemorrhage during the subsequent study. 17. no matter how serious it is, there is any patient with any signs of hemorrhagic physical or medical history; there is no wound, ulcer or fracture in patients with any bleeding or bleeding more than CTCAE 3 within the first 4 weeks of the group; 18. in 6 months, there were hyperactivity / venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism. 19. patients with tumor thrombus; 20. with a single tumor diameter greater than 20cm patients; 21. those who had a history of psychotic drug abuse and could not quit or had mental disorders. 22. alcohol dependence and abuse history. 23. accompanied by other diseases of the tumor or blood system; 24. at the same time, use other red blood cells as the target drugs, including traditional Chinese medicine (e. gelatin), or participated in other clinical trials within four weeks. 25. according to the researchers' judgement, there are patients who are seriously endangering the safety of patients or affecting the patients who completed the research. 26. other researchers bel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemoglobin; | — |
Countries
China
Contacts
Public ContactJun Shi
Shanghai Sixth People's hospital
Outcome results
None listed