PHASE 2 STUDY TO ASSESS THE EFFICACY OF THALIDOMIDE IN EWING SARCOMA, A FORM OF BONE AGGRESSIVE BONE CANCER
- Conditions
- Health Condition 1: null- Recurrent locally advanced / metastatic Ewing sarcoma patients who have failed conventional treatment
- Registration Number
- CTRI/2011/07/001871
- Lead Sponsor
- DEPT OF SCIENCE AND TECHNOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CLINICAL AND RADIOLOGICAL RESPONSETimepoint: MONTHLY FOR ONE YEAR
- Secondary Outcome Measures
Name Time Method Overall survivalTimepoint: Monthly
Related Research Topics
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