Health Condition 1: null- Recurrent locally advanced / metastatic Ewing sarcoma patients who have failed conventional treatment
Conditions
Interventions
Intervention1: THALIDOMIDE: The patients will be started on 100mg/m2/day and if the dose was tolerated for 7 days without non-hematologic toxicity of more than grade 2, then the dose will be increased
Sponsors
DEPT OF SCIENCE AND TECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLINICAL AND RADIOLOGICAL RESPONSETimepoint: MONTHLY FOR ONE YEAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: Monthly | — |
Countries
India
Contacts
Public ContactDRTRAJKUMAR
CANCER INSTITUTE (WIA)
Outcome results
None listed