Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
NCT ID: NCT00716976
Last Updated: 2023-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2008-06-23
2021-06-30
Brief Summary
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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.
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Detailed Description
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Primary
* To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
Secondary
* To compare the mean change in hearing thresholds for key frequencies in these patients.
* To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients.
* To compare the event-free survival and overall survival of these patients.
* To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial radiation (yes vs no), age (\< 5 years vs ≥ 5 years) and duration of cisplatin infusion (\< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms.
* Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
* Arm II (observation): Patients do not receive sodium thiosulfate.
Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some patients may undergo saliva collection for DNA studies.
After completion of study, patients are followed periodically for 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Interventions
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sodium thiosulfate
Given IV
examination
Patients undergo audiological assessments periodically
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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., 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.
1 Year
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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David R. Freyer, DO, MS
Role: STUDY_CHAIR
Children's Hospital Los Angeles
Locations
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UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
National Naval Medical Center
Bethesda, Maryland, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Cancer Institute
Durham, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
Countries
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References
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Freyer DR, Chen L, Krailo MD, Knight K, Villaluna D, Bliss B, Pollock BH, Ramdas J, Lange B, Van Hoff D, VanSoelen ML, Wiernikowski J, Neuwelt EA, Sung L. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jan;18(1):63-74. doi: 10.1016/S1470-2045(16)30625-8. Epub 2016 Dec 1.
Other Identifiers
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COG-ACCL0431
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000588655
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL0431
Identifier Type: -
Identifier Source: org_study_id
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