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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Newly diagnosed with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy
previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study
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
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
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.

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