Low Dose Chemotherapy Versus Best Supportive Care in Progressive Pediatric Malignancies

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

January 31, 2017

Conditions
Malignant Childhood Neoplasm
Interventions
DRUG

Low dose chemotherapy

"Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size.~Cycle A~* Daily oral Thalidomide (at 3mg/kg)~* Daily oral Celecoxib (100 mg BID for patients \< 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients \> 50 kg)~* Daily oral Etoposide (50 mg/m2/d)~Cycle B~* Daily oral Thalidomide (at 3mg/kg)~* Daily oral Celecoxib (100 mg BID for patients \< 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients \> 50 kg)~* Daily oral Cyclophosphamide (2.5 mg/kg/d to a maximum of 100 mg/d) every 21 days"

Trial Locations (1)

110029

All India Institute of Medical Sciences, New Delhi

All Listed Sponsors
lead

All India Institute of Medical Sciences

OTHER

NCT01858571 - Low Dose Chemotherapy Versus Best Supportive Care in Progressive Pediatric Malignancies | Biotech Hunter | Biotech Hunter