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This study evaluates the drug Sodium Thiosulfate to prevent hearing loss in children receiving cisplatin chemotherapy. It included patients with cancers such as germ cell tumor, hepatoblastoma, neuroblastoma, or osteosarcoma who had normal hearing. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.