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Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, or Osteosarcoma
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase III Randomized Study of Sodium Thiosulfate in Preventing Ototoxicity in Young Patients Receiving Cisplatin Chemotherapy for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, or Osteosarcoma
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Supportive care, Treatment
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Active
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1 to 18
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NCI
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COG-ACCL0431
ACCL0431, NCT00716976
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Trial Description Purpose: 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.
This randomized phase III trial is studying sodium thiosulfate to see how well it works compared with no additional treatment in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, or osteosarcoma. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Patients will be randomly assigned (have an equal chance of being placed) to one of two groups. Patients in group one will receive an infusion of sodium thiosulfate beginning 6 hours after each cisplatin infusion. Sodium thiosulfate infusions may continue until treatment with cisplatin is finished. Patients in group two will not receive sodium thiosulfate. Patients will undergo hearing tests at the beginning of the study, before each course of cisplatin, and at 4 weeks and 1 year after finishing cisplatin or other cancer treatment. After finishing treatment, patients will be evaluated periodically for 10 years.
Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site.
Trial Contact Information
Trial Lead Organizations Children's Oncology Group | | | | David Freyer, DO, MS, Protocol chair | | | |
Trial Sites
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| U.S.A. |
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| Alabama |
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Birmingham |
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| | | | | | | | | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham |
| | | Clinical Trials Office - Lurleen Wallace Comprehensive Cancer | |
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| California |
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Los Angeles |
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| | | | Childrens Hospital Los Angeles |
| | | Leo Mascarenhas | |
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Madera |
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| | | Children's Hospital Central California |
| | | Vonda Crouse | |
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San Diego |
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| | | Rady Children's Hospital - San Diego |
| | | Clinical Trials Office - Rady Children's Hospital - San Diego | |
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San Francisco |
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| | | UCSF Helen Diller Family Comprehensive Cancer Center |
| | | Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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| Connecticut |
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Farmington |
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| | | | Carole and Ray Neag Comprehensive Cancer Center at the
University of Connecticut Health Center |
| | | Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center | |
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| Florida |
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Fort Myers |
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| | | | Lee Cancer Care of Lee Memorial Health System |
| | | Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System | |
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Tampa |
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| | | St. Joseph's Cancer Institute at St. Joseph's Hospital |
| | | Clinical Trials Office - St. Joseph's Cancer Institute | |
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West Palm Beach |
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| | | Kaplan Cancer Center at St. Mary's Medical Center |
| | | Narayana Gowda | |
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| Idaho |
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Boise |
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| | | | Mountain States Tumor Institute at St. Luke's Regional Medical Center |
| | | Eugenia Chang | |
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| Indiana |
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Indianapolis |
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| | | | Indiana University Melvin and Bren Simon Cancer Center |
| | | Clinical Trials Office - Indiana University Cancer Center | |
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| Iowa |
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Des Moines |
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| | | | Blank Children's Hospital |
| | | Clinical Trials Office - Blank Children's Hospital | |
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| Michigan |
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Flint |
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| | | | Hurley Medical Center |
| | | Clinical Trials Office - Hurley Medical Center | |
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Grand Rapids |
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| | | Butterworth Hospital at Spectrum Health |
| | | David Dickens | |
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| Nevada |
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Las Vegas |
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| | | | CCOP - Nevada Cancer Research Foundation |
| | | Jonathan Bernstein | |
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| New York |
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Albany |
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| | | | Albany Medical Center Hospital |
| | | Vikramjit Kanwar | |
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New York |
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| | | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center |
| | | Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
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Valhalla |
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| | | New York Medical College |
| | | Fevzi Ozkaynak | |
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| North Carolina |
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Charlotte |
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| | | | Blumenthal Cancer Center at Carolinas Medical Center |
| | | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
| | | Presbyterian Cancer Center at Presbyterian Hospital |
| | | Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital | |
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| Ohio |
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Akron |
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| | | | Akron Children's Hospital |
| | | Clinical Trials Office - Akron Children's Hospital | |
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Cincinnati |
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| | | Cincinnati Children's Hospital Medical Center |
| | | Clinical Trials Office - Cincinnati Children's Hospital Medical Center | |
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Columbus |
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| | | Nationwide Children's Hospital |
| | | Amanda Termuhlen | |
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| Oklahoma |
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Oklahoma City |
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| | | | Oklahoma University Cancer Institute |
| | | Rene McNall-Knapp | |
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| Pennsylvania |
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Pittsburgh |
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| | | | Children's Hospital of Pittsburgh |
| | | Clinical Trials Office - Children's Hospital of Pittsburgh | |
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| Texas |
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Fort Worth |
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| | | | Cook Children's Medical Center - Fort Worth |
| | | Clinical Trials Office - Cook's Children's Medical Center | |
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San Antonio |
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| | | University of Texas Health Science Center at San Antonio |
| | | Paul Thomas | |
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| Wisconsin |
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Marshfield |
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| | | | Marshfield Clinic - Marshfield Center |
| | | Clinical Trials Office - Marshfield Clinic - Marshfield Center | | Ph: | 800-782-1581 ext. 94457 | | |
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| Registry Information | | | Official Title | | A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children | | | Trial Start Date | | 2008-06-23 | | | Trial Completion Date | | 2012-07-01 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00716976 | | | Date Submitted to PDQ | | 2008-06-12 | | | Information Last Verified | | 2009-01-13 |
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