A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Inclusion 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., Headstart) allowed

- No concurrent cranial irradiation during the chemotherapy regimen (i.e., prior to the
administration of the final dose of cisplatin)

- 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