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

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00716976

2. Intervention

   Sodium thiosulfate

3. Intervention

   Examination

4. Additional Topic(s)

   Ototoxicity

5. Resource Description

   Cisplatin is a chemotherapy medicine that is used for many types of childhood cancer. Cisplatin can cause side effects to the blood and kidney systems. Cisplatin may also cause a side effect called ototoxicity. Ototoxicity is damage to the hearing system that causes hearing loss or ringing in the ears (tinnitus). This hearing loss can be permanent. Sodium thiosulfate (STS) is a medicine that may prevent this kind of hearing loss. The goal of this research study is to evaluate if STS can prevent hearing loss in participants receiving cisplatin chemotherapy for newly diagnosed cancers.

6. Additional Name

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

7. Contact

   Berenberg, Jeffrey

8. PI

   Wilkinson, Robert, M.D.

9. Topic

   sarcoma

10. Topic

    brain cancer

11. Topic

    ovarian cancer

12. Topic

    germ cell and embryonal cancer

13. Topic

    liver cancer

14. Topic

    central nervous system cancer

15. Topic

    neuroblastoma

16. Study Population

    Patients must 1 year of age or older, but younger than 19 years old.

17. Funded by

    Children's Oncology Group

18. Phase

    Phase 3 clinical trial

19. Performed by

    Clinical Protocol & Data Management Shared Resource