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 currently recruiting participants.
Verified July 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00716976
First received: July 15, 2008
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 compared with no additional treatment in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Liver Cancer
Neuroblastoma
Ototoxicity
Ovarian Cancer
Sarcoma
Drug: sodium thiosulfate
Procedure: examination
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of hearing loss [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in hearing thresholds for key frequencies [ Designated as safety issue: No ]
  • Incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia [ Designated as safety issue: Yes ]
  • Event-free-survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: June 2008
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: sodium thiosulfate
Given IV
Procedure: examination
Patients undergo audiological assessments periodically
No Intervention: Arm II (observation)
Patients do not receive sodium thiosulfate.
Procedure: examination
Patients undergo audiological assessments periodically

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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., Headstart) allowed
  • No concurrent cranial irradiation during the chemotherapy regimen (i.e., prior to the administration of the final dose of cisplatin)

    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716976

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center     205-934-0309        
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni     501-686-8274        
United States, California
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas     323-361-2529        
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Robert M. Cooper     323-783-5307        
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego     858-966-5934        
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Clinical Trials Office - Connecticut Children's Medical Center     860-545-9967        
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center     203-785-5702        
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre     302-651-5755        
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Clinical Trials Office - Children's National Medical Center     202-884-2549        
United States, Florida
Lee Cancer Care of Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt     877-680-0008        
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric S. Sandler     904-697-3793        
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Ramamoorthy Nagasubramanian     407-650-7230        
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute     407-303-5623        
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz     850-505-4790        
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale     727-767-4176        
St. Joseph's Cancer Institute at St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute     800-882-4123        
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii     808-586-2979        
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang     208-381-2731        
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61603
Contact: Pedro A. De Alarcon     309-655-4242        
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202-5225
Contact: James M. Croop     317-944-8784        
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - Blank Children's Hospital     515-241-6729        
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital     502-629-5500     CancerResource@nortonhealthcare.org    
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Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center     504-988-6121        
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Clinical Trials Office - Children's Hospital of New Orleans     504-894-5377        
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National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Melissa A. Forouhar     253-968-6144        
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
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Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
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Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007-5381
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United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M     612-813-5193        
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington     816-234-3265        
Cardinal Glennon Children's Hospital Recruiting
St. Louis, Missouri, United States, 63104
Contact: William S. Ferguson     314-577-5638        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein     702-732-1493        
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center     973-926-3136        
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University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, North Carolina
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute     888-275-3853        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-2799        
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Yousif (Joe) H. Matloub     216-844-3345        
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Laura T. Martin     614-722-3582        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp     405-271-5311        
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea     503-494-1080     trials@ohsu.edu    
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital     503-413-2560        
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone     484-884-3333        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-7056        
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C     401-444-1488        
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Tennessee
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais     865-541-8266        
United States, Texas
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Clinical Trials Office - Driscoll Children's Hospital     361-694-5311        
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Anne-Marie R. Langevin     210-567-7477        
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe     757-668-7243        
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy L. Felgenhauer     509-474-2777        
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine H. Cole     011-6189340-8238        
Canada, British Columbia
Children's and Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf     604-875-3576        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky     204-787-4163        
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap     902-470-8778        
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M.L. Halton     613-737-7600x2370        
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel     416-813-7795        
Canada, Quebec
Hopital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson     514-345-4931x2790        
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Mpofu     306-655-2744        
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon     418-656-4141X47191        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: David R. Freyer, DO, MS Children's Hospital Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Brad H. Pollock, Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00716976     History of Changes
Other Study ID Numbers: CDR0000588655, COG-ACCL0431
Study First Received: July 15, 2008
Last Updated: July 12, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ototoxicity
childhood central nervous system germ cell tumor
childhood extracranial germ cell tumor
childhood extragonadal germ cell tumor
childhood malignant testicular germ cell tumor
childhood malignant ovarian germ cell tumor
childhood teratoma
childhood medulloblastoma
disseminated neuroblastoma
regional neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
stage 4S neuroblastoma
localized osteosarcoma
metastatic osteosarcoma
childhood hepatoblastoma
stage I childhood liver cancer
stage II childhood liver cancer
stage III childhood liver cancer
stage IV childhood liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Medulloblastoma
Nervous System Neoplasms
Neuroblastoma
Osteosarcoma
Ovarian Neoplasms
Central Nervous System Neoplasms
Neoplasms, Germ Cell and Embryonal
Hepatoblastoma
Sarcoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on May 16, 2013