A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
N/A
1 Year
18 Years
1 Year
18 Years
Open (Enrolling)
Both
Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific
Both
Ototoxicity, Unspecified Childhood Solid Tumor, Protocol Specific
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 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 |
| New York Medical College | Valhalla, New York 10595 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| 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 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| 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 |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
| 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 |
| Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
| 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 |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto, California 95798 |
| 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 |
