Status:
COMPLETED
Low Dose Chemotherapy Versus Best Supportive Care in Progressive Pediatric Malignancies
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Malignant Childhood Neoplasm
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The u...
Detailed Description
Many of the pediatric malignancies are not curable on progression on front line or 2nd line chemotherapy. Further therapy with conventional drugs imposes many side effects and decreases the QOL. The u...
Eligibility Criteria
Inclusion
- Refractory/Progressive non hematopoietic extracranial solid tumors following treatment with at least 2 lines of chemotherapy.
- ECOG performance status (\<=3)(at least patients ambulating with crutches or on wheel chair)
- Age: 5-18 years
- Recovered from all acute toxic effects of earlier therapy
- Absolute neutrophil count \> 1X 109/L
- Absolute platelet count \> 75 x 109/L
- Normal renal functions
- Serum bilirubin \<1.5 times the upper limit of normal, and the serum aspartate aminotransferase and alanine aminotransferase \< 5 times the upper limit of normal.
Exclusion
- Uncontrolled concurrent illness or active infection
- Positive serology for human immunodeficiency.
- Unable to swallow oral medication
- Pregnant and breast-feeding
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01858571
Start Date
October 1 2013
End Date
January 1 2017
Last Update
January 25 2017
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029