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A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy


N/A
1 Year
18 Years
Open (Enrolling)
Both
Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy


OBJECTIVES:

- Determine the optimal criteria for determination of ototoxicity in younger cancer
patients treated with cisplatin.

- Determine the feasibility of including ultrahigh frequency and evoked otoacoustic
emission testing as adjunctive measures of ototoxicity.

- Determine the feasibility and necessity of central review of audiometry data.

OUTLINE: This is a multicenter, prospective, cohort study.

Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic
emission testing) before the first course of planned cisplatin, before each subsequent
course of cisplatin, and 4 weeks after the last dose of cisplatin.

Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation
undergo hearing tests before the transplantation and 4 weeks after transplantation.

PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Planning to undergo treatment with any cisplatin-containing therapeutic regimen for
cancer

- Treatment does not need to be on a COG therapeutic study

- Planning to enroll on clinical trial ACCL0431

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior cisplatin

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Lillian Sung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

United States: Federal Government

Study ID:

ACCL05C1

NCT ID:

NCT00458887

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Ototoxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • ototoxicity
  • unspecified childhood solid tumor, protocol specific

Name

Location

National Naval Medical CenterBethesda, Maryland  20889
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Bronson Methodist HospitalKalamazoo, Michigan  49007
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Driscoll Children's HospitalCorpus Christi, Texas  78466
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Blank Children's HospitalDes Moines, Iowa  50309
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Childrens Hospital Los AngelesLos Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Riley's Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
Duke Cancer InstituteDurham, North Carolina  27710
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503
Legacy Emanuel Children's HospitalPortland, Oregon  97227