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
Intervention: sodium thiosulfate; examination
Intervention description: Given IV; Patients undergo audiological assessments periodically
Intervention MeSH terms: Sodium thiosulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed (previously untreated or currently receiving cancer treatment for the
             diagnosis that made the patient eligible for this study) with germ cell tumor,
             hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy

          -  Planning to receive a chemotherapy treatment regimen that includes a cumulative
             cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6
             hours

          -  Enrolled on hearing assessment clinical trial COG-ACCL05C1

               -  Normal auditory results

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)

          -  Lansky PS 50-100% (for patients ≤ 16 years of age)

          -  Serum sodium normal

          -  Absolute granulocyte count > 1,000/mm³

          -  Platelet count > 100,000/mm³

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum
             creatinine between 0.4 and 1.7 mg/dL, based on age and gender

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

          -  AST or ALT < 2.5 times ULN for age

          -  Not pregnant or nursing

          -  Negative pregnancy test (if patient has child-bearing capacity)

          -  Fertile patients must use effective contraception

          -  No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g.,
             amifostine trihydrate, N-acetylcysteine, MESNA, or captopril)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior platinum-based chemotherapy (cisplatin or carboplatin)

               -  Other prior chemotherapy allowed

          -  Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided
             normal hearing is documented after completion of radiotherapy and before enrollment
             and administration of cisplatin chemotherapy

          -  At least 6 months since prior hematopoietic stem cell transplantation.

               -  No evidence of graft-versus-host disease

          -  No concurrent enrollment on another COG clinical trial for treatment of the cancer.

               -  Concurrent enrollment on a non-COG clinical trial (e.g., Head start) allowed.

          -  Cranial irradiation after the completion of all systemic chemotherapy allowed provided
             post end-of-treatment audiometry is completed prior to beginning irradiation.

          -  Concurrent radiotherapy to extracranial sites allowed.