Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Condition: Brain Tumor; Central Nervous System Tumor; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Liver Cancer; Neuroblastoma; Ototoxicity; Ovarian Cancer; Sarcoma
MeSH terms: Neoplasms; Liver Neoplasms; Neuroblastoma; Neoplasms, Germ Cell and Embryonal; Osteosarcoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma; Hepatoblastoma; Ototoxicity
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss
           in young patients receiving cisplatin for the treatment of newly diagnosed germ cell
           tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other
           malignancy.

      Secondary

        -  To compare the mean change in hearing thresholds for key frequencies in these patients.

        -  To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3
           and 4 cytopenia in these patients.

        -  To compare the event-free survival and overall survival of these patients.

        -  To evaluate the association of two key gene mutations (TPMT and COMT) with the
           development of cisplatin-induced hearing loss in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial
      radiation (yes vs no), age (< 5 years vs ≥ 5 years) and duration of cisplatin infusion (< 2
      hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms.

        -  Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes
           beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium
           thiosulfate continues until the completion of cisplatin therapy.

        -  Arm II (observation): Patients do not receive sodium thiosulfate.

      Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and
      then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some
      patients may undergo saliva collection for DNA studies.

      After completion of study, patients are followed periodically for 10 years.
    

Intervention name(s): sodium thiosulfate; examination
Intervention type(s): Drug; Procedure
Intervention description(s): Given IV; Patients undergo audiological assessments periodically
Other intervention name(s): ADH300001; Disodium Thiosulfate Pentahydrate; Na Thiosulfate; Sodium Hyposulfite; Sodium Thiosulphate; Thiosulfuric Acid; Disodium Salt; Pentahydrate; Versiclear; NSC# 45624; IND#72877
Intervention MeSH terms: Sodium thiosulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ototoxicity; childhood central nervous system germ cell tumor; childhood extracranial germ cell tumor; childhood extragonadal germ cell tumor; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood teratoma; childhood medulloblastoma; disseminated neuroblastoma; regional neuroblastoma; localized resectable neuroblastoma; localized unresectable neuroblastoma; stage 4S neuroblastoma; localized osteosarcoma; metastatic osteosarcoma; childhood hepatoblastoma; stage I childhood liver cancer; stage II childhood liver cancer; stage III childhood liver cancer; stage IV childhood liver cancer