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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00716976
First received: July 15, 2008
Last updated: January 7, 2014
Last verified: January 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Brain Tumor
Central Nervous System Tumor
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Interventions: Drug: sodium thiosulfate
Procedure: examination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
STS Arm (Sodium Thiosulfate Treatment)

Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.

sodium thiosulfate: Given IV

examination: Patients undergo audiological assessments periodically.

Observation Arm (No Sodium Thiosulfate Treatment)

Patients do not receive sodium thiosulfate.

examination: Patients undergo audiological assessments periodically.


Participant Flow:   Overall Study
    STS Arm (Sodium Thiosulfate Treatment)     Observation Arm (No Sodium Thiosulfate Treatment)  
STARTED     65     66  
COMPLETED     45     57  
NOT COMPLETED     20     9  
Adverse Event                 2                 0  
Death                 1                 0  
Physician Decision                 2                 2  
Withdrawal by Subject                 6                 1  
Premature discontinuation of Cisplatin                 5                 4  
Admin cranial radiation prior to test                 1                 0  
Ineligible                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
STS Arm (Sodium Thiosulfate Treatment)

Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.

sodium thiosulfate: Given IV

examination: Patients undergo audiological assessments periodically

Observation Arm (No Sodium Thiosulfate Treatment)

Patients do not receive sodium thiosulfate.

examination: Patients undergo audiological assessments periodically

Total Total of all reporting groups

Baseline Measures
    STS Arm (Sodium Thiosulfate Treatment)     Observation Arm (No Sodium Thiosulfate Treatment)     Total  
Number of Participants  
[units: participants]
  65     66     131  
Age  
[units: years]
Mean ± Standard Deviation
  8.97  ± 5.93     8.39  ± 5.88     8.68  ± 5.89  
Age  
[units: participants]
     
<=18 years     65     66     131  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     27     24     51  
Male     38     42     80  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     1     2     3  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     7     10     17  
White     44     41     85  
More than one race     0     0     0  
Unknown or Not Reported     11     12     23  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     19     15     34  
Not Hispanic or Latino     44     48     92  
Unknown or Not Reported     2     3     5  
Region of Enrollment [1]
[units: participants]
     
United States     56     62     118  
Canada     8     4     12  
[1] One patient in the STS Arm has an unknown region of enrollment.



  Outcome Measures

1.  Primary:   Incidence of Hearing Loss   [ Time Frame: 4 weeks after last dose of cisplatin ]

2.  Secondary:   Change in Hearing Thresholds for Key Frequencies   [ Time Frame: 4 weeks after last dose of cisplatin ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Event-free-survival   [ Time Frame: Up to 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: Up to 10 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)   [ Time Frame: 4 weeks after the last dose of cisplatin ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


No publications provided


Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00716976     History of Changes
Other Study ID Numbers: ACCL0431, COG-ACCL0431, CDR0000588655
Study First Received: July 15, 2008
Results First Received: January 6, 2014
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration