CTRI/2011/07/001871Other2 期
PHASE 2 STUDY TO ASSESS THE EFFICACY OF THALIDOMIDE IN METASTATIC RECURRENT EWING SARCOMA
DEPT OF SCIENCE AND TECHNOLOGY0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Confirmed histopathological diagnosis of Ewing sarcoma
- •2.Presence of type 1 EWS-FLI1 fusion gene confirmed by sequencing.
- •3.Recurrent, locally advanced / metastatic disease
- •4.PS 1 ¨C 2
- •5.Informed consent mandatory
- •6.Clinically or radiologically or pathologically (bone marrow) evaluable metastatic disease
- •7.Adequate haematological parameters: haemoglobin 9g/dl; total granulocyte count 1500/mm3; platelet count 75,000 / mm3
- •8.BUN 45 mg/dl; creatinine 2 mg/dl
- •9.Alkaline phospatase; aspartate aminotransferase less than thrice the upper limit of normal; s.bilirubin ¡Ü2mg/dl
- •10. Prothrombin time no greater than1.4 times control, unless therapeutically warranted.
排除标准
- •1.Pregnant or Lactating women.
- •2.Severe pulmonary or cardiac disease.
- •3.Brain or spinal cord metastasis.
- •4.Uncontrolled diabetes or hypertension (will need to be optimally controlled before recruitment to the study).
- •5.Presence of an acute infection requiring active treatment.
- •6.Women patients in the child bearing age will be required to use a medically accepted form of birth control during the study. A positive serum pregnancy test within 48 hours to starting Thalidomide, will exclude the patient.
研究者
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