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Last Modified: 5/22/2008     First Published: 4/2/2007  
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Prospective Study of Ototoxicity Assessment in Younger Cancer Patients Treated With Cisplatin

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified


Natural history/Epidemiology, Supportive care


Active


30 and under


NCI


COG-ACCL05C1
ACCL05C1, NCT00458887

Objectives

  1. Determine the optimal criteria for determination of ototoxicity in younger cancer patients treated with cisplatin.
  2. Determine the feasibility of including ultrahigh frequency and evoked otoacoustic emission testing as adjunctive measures of ototoxicity.
  3. Determine the feasibility and necessity of central review of audiometry data.

Entry 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

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • No prior cisplatin

Patient Characteristics:

  • Not specified

Expected Enrollment

150

A total of 150 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Lillian Sung, MD, PhD, Protocol chair
Ph: 416-813-5287

Trial Sites

U.S.A.
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas
Ph: 323-361-2529
  Madera
 Children's Hospital Central California
 Vonda Crouse
Ph: 559-353-5480
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center
Ph: 800-579-7822
District of Columbia
  Washington
 Children's National Medical Center
 Clinical Trials Office - Children's National Medical Center
Ph: 202-884-2549
Florida
  St. Petersburg
 All Children's Hospital
 Jerry Barbosa
Ph: 727-767-4176
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Howard Katzenstein
Ph: 404-785-0853
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
Iowa
  Des Moines
 Blank Children's Hospital
 Clinical Trials Office - Blank Children's Hospital
Ph: 515-241-6729
Michigan
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 David Dickens
Ph: 616-391-2086
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Clinical Trials Office - Children's Hospitals and Clinics of Minnesota
Ph: 612-813-5193
 Masonic Cancer Center at University of Minnesota
 Clinical Trials Office - Masonic Cancer Center at University of Minnesota
Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail Megason
Ph: 601-984-5220
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert Hayashi
Ph: 314-454-4118
Nevada
  Las Vegas
 Sunrise Hospital and Medical Center
 Jonathan Bernstein
Ph: 702-732-1493
New Jersey
  Morristown
 Overlook Hospital
 Hazem Mahmoud
Ph: 973-971-6720
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Carolina
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 Clinical Trials Office - Cincinnati Children's Hospital Medical Center
Ph: 513-636-0161
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
  Columbus
 Nationwide Children's Hospital
 Amanda Termuhlen
Ph: 614-722-3552
Oregon
  Portland
 Oregon Health and Science University Cancer Institute
 Clinical Trials Office - Oregon Health and Science University Cancer Institute
Ph: 503-494-1080
 Email: trials@ohsu.edu
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Peter Adamson
Ph: 215-590-6359
  Pittsburgh
 Children's Hospital of Pittsburgh
 Clinical Trials Office - Children's Hospital of Pittsburgh
Ph: 412-692-5573
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
  Greenville
 Greenville Hospital Cancer Center
 Clinical Trials Office - Greenville Hospital Cancer Center
Ph: 864-241-6251
Texas
  Corpus Christi
 Driscoll Children's Hospital
 Clinical Trials Office - Driscoll Children's Hospital
Ph: 361-694-5311
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Ph: 866-460-4673; 214-648-7097
  San Antonio
 University of Texas Health Science Center at San Antonio
 Paul Thomas
Ph: 210-704-2187
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip Barnette
Ph: 801-662-4700
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Douglas Hawkins
Ph: 206-987-3096
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Ph: 608-262-5223
  Marshfield
 Marshfield Clinic - Marshfield Center
 Clinical Trials Office - Marshfield Clinic - Marshfield Center
Ph: 800-782-1581 ext. 94457
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Bruce Camitta
Ph: 414-456-4106
Australia
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine Cole
Ph: 011-6189340-8238
Canada
  Quebec
 Centre Hospitalier Universitaire de Quebec
 Yvan Samson
Ph: 418-656-4141x47191
Manitoba
  Winnipeg
 CancerCare Manitoba
 Rochelle Yanofsky
Ph: 204-787-4163
Ontario
  Toronto
 Hospital for Sick Children
 Ronald Grant
Ph: 416-813-8885
Quebec
  Montreal
 Montreal Children's Hospital at McGill University Health Center
 Sharon Abish
Ph: 514-412-4400x22219
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Kaiser Ali
Ph: 306-655-2744

Registry Information
Official Title A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
Trial Start Date 2007-05-07
Trial Completion Date 2009-05-06 (estimated)
Registered in ClinicalTrials.gov NCT00458887
Date Submitted to PDQ 2007-02-26
Information Last Verified 2008-05-22
NCI Grant/Contract Number CA095861

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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