Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

January 4, 2016

Study Completion Date

October 1, 2016

Conditions
OsteosarcomaNephrotoxicityOtotoxicity
Interventions
DRUG

Pantoprazole

0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 \& 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 \& 2 of treatment Cycles 1 \& 2 (Treatment Arms 1, 3) OR Cycles 3 \& 4 (Treatment Arms 2, 4)

DRUG

High-dose methotrexate infusion duration

High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

Trial Locations (1)

19104

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
collaborator

Gateway for Cancer Research

OTHER

lead

Children's Hospital of Philadelphia

OTHER

NCT01848457 - Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy | Biotech Hunter | Biotech Hunter