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



Status:Completed
Conditions:Ovarian Cancer, Liver Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 18
Updated:9/22/2018
Start Date:June 2008
End Date:April 9, 2015

Use our guide to learn which trials are right for you!

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

RATIONALE: 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.

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.

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.

DISEASE CHARACTERISTICS:

- Newly diagnosed (previously untreated or currently receiving cancer treatment for the
diagnosis that made the patient eligible for this study) with germ cell tumor,
hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy

- Planning to receive a chemotherapy treatment regimen that includes a cumulative
cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6
hours

- 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.
We found this trial at
69
sites
2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1802 6th Avenue South
Birmingham, Alabama 35294
(205) 934-4011
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas From its...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
?
mi
from
Danville, PA
Click here to add this to my saved trials
1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
?
mi
from
Flint, MI
Click here to add this to my saved trials
2776 Cleveland Ave
Fort Myers, Florida 33905
(239) 343-9500
Lee Cancer Care of Lee Memorial Health System Our origins can be traced to the...
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
30 Prospect Avenue
Hackensack, New Jersey 07601
(201) 996-5900
Hackensack University Medical Center Cancer Center The mission of the John Theurer Cancer Center is...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
701 Ilalo Street Suite 600
Honolulu, Hawaii 96813
808-586-3010
Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
9300 Valley Children's Pl
Madera, California 93720
(559) 353-3000
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
?
mi
from
Madera, CA
Click here to add this to my saved trials
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
701 West 168th Street
New York, New York 10032
(212) 851-4680
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center The Herbert Irving Comprehensive Cancer...
?
mi
from
New York, NY
Click here to add this to my saved trials
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
800 NE 10th Street
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
2501 N Orange Ave # 235
Orlando, Florida 32804
(407) 303-1700
Florida Hospital Cancer Institute at Florida Hospital Orlando FHCI is the largest cancer center in...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Comprehensive Cancer Center The Comprehensive Cancer Center at Rhode Island Hospital is...
?
mi
from
Providence, RI
Click here to add this to my saved trials
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
105 West 8th Avenue
Spokane, Washington 99220
(509) 474-3131
Providence Cancer Center at Sacred Heart Medical Center When Mother Joseph and the Sisters of...
?
mi
from
Spokane, WA
Click here to add this to my saved trials
750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
3001 W Dr Martin L King Jr
Tampa, Florida 33607
(813) 870-4123
St. Joseph's Cancer Institute at St. Joseph's Hospital St. Joseph's Hospital is known for its...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
1415 Tulane Ave., HC-62
Alexandria, Louisiana 70112
504-988-6121
Tulane Cancer Center Office of Clinical Research As an academic cancer center, Tulane offers our...
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Bethesda, Maryland 20889
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
?
mi
from
Durham, NC
Click here to add this to my saved trials
705 Riley Hospital Drive
Indianapolis, Indiana 46202
317.944.2060
Riley's Children Cancer Center at Riley Hospital for Children The Riley Hospital for Children Cancer...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Perth, Western Australia
?
mi
from
Perth,
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
2801 N Gantenbein Ave
Portland, Oregon 97227
(503) 276-6500
Legacy Emanuel Children's Hospital For generations our children's hospital has provided outstanding care for kids...
?
mi
from
Portland, OR
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63104
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Sioux Falls, South Dakota 57117
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials