drugset / Trial / NCT00716976

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

NCT00716976

RandomizedParallel-groupOpen-labelSupportive care

Summary

RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.

Timeline

Start
2008-06-23
Primary completion
2015-04-09
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Thiosulfate Diagnostic / imaging agent 533 mg/kg Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 16000 mg/m2 Intravenous