Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified
Conditions
Interventions
Intervention1: Ifosfamide Etoposide chemotherapy: Ifosfamide and Etoposide chemotherapy will be given to participants who fulfill the inclusion criteria
FREQUENCY - EVERY 3 WEEKS
DURATION - FOR A TO
Sponsors
Department of Medical Oncology
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent Age of 5 to 50 years Histologically proven Ewing’s sarcoma at initial diagnosis or recurrence Distant or combined (local plus distant) relapse Exposure to Ifosfamideand etoposide more than 12 months ago Progression after atleast one line of treatment ECOG PS 0-2 ANC more than 1000 per microlitre Hemoglobin more than 8 g per dL Platelet more than 1 lac per microlitre Creatinine less than 1.5 times ULN eGFR more than 30ml per min (Cockcroft-Gault) Total bilirubin less than 5 times ULN ALT and AST less than 5 times ULN, alkaline phosphatase less than 2.5 times ULN
Exclusion criteria
Exclusion criteria: Cytotoxic chemotherapy within 2 weeks Radiation therapy within 6 weeks Active or uncontrolled infection Isolated local recurrence amenable to curative surgical resection Previous CTCAE v.5 grade 3 or 4 acute kidney injury / encephalopathy or neurotoxicity / myelosuppression due to prior ifosfamide or etoposide treatment Active heart disease, uncontrolled hypertension and arterial or venous thrombotic disease Pregnant or breastfeeding patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (Complete response plus Partial Response) RatesTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response Progression Free Rate at 3 months QoL Side effect Profile Timepoint: 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Anand Shahi
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed