A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
OBJECTIVES:
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Incidence of hearing loss
No
David R. Freyer, DO, MS
Study Chair
Children's Hospital Los Angeles
Unspecified
CDR0000588655
NCT00716976
June 2008
Name | Location |
---|---|
National Naval Medical Center | Bethesda, Maryland 20889 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania 18017 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan 49503 |
Legacy Emanuel Children's Hospital | Portland, Oregon 97227 |