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

Not Recruiting

Trial ID: NCT00716976


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.

Official Title

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

Stanford Investigator(s)



   - 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

   - 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)


   - 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.


drug: sodium thiosulfate

procedure: examination

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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