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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 1 to 18 NCI COG-ACCL05C1
ACCL05C1, NCT00458887

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.

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
Planning to enroll on clinical trial ACCL0431

Prior/Concurrent Therapy:

See Disease Characteristics
No prior cisplatin

Patient Characteristics:

Not specified

Expected Enrollment

282

A total of 282 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.

Alabama

Birmingham

UAB Comprehensive Cancer Center

Clinical Trials Office - UAB Comprehensive Cancer Center
Ph: 205-934-0309

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

Long Beach

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

Jerry Finklestein
Ph: 562-492-1062

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 Diego

Rady Children's Hospital - San Diego

Clinical Trials Office - Rady Children's Hospital - San Diego
Ph: 858-966-5934

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center

Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222

Stanford

Stanford Cancer Center

Clinical Trials Office - Stanford Cancer Center
Ph: 650-498-7061

Email: cctoffice@stanford.edu

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

Delaware

Wilmington

Alfred I. duPont Hospital for Children

Clinical Trials Office - Alfred I. duPont Hospital for Children
Ph: 302-651-5755

District of Columbia

Washington

Children's National Medical Center

Clinical Trials Office - Children's National Medical Center
Ph: 202-884-2549

Florida

Fort Myers

Lee Cancer Care of Lee Memorial Health System

Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System
Ph: 877-680-0008

Jacksonville

Nemours Children's Clinic

Eric Sandler
Ph: 904-697-3793

Orlando

Nemours Children's Clinic - Orlando

Paul Gordon
Ph: 407-650-7330

St. Petersburg

All Children's Hospital

Gregory Hale
Ph: 727-767-4176

Tampa

St. Joseph's Cancer Institute at St. Joseph's Hospital

Clinical Trials Office - St. Joseph's Cancer Institute
Ph: 800-882-4123

West Palm Beach

Kaplan Cancer Center at St. Mary's Medical Center

Narayana Gowda
Ph: 561-844-6363

Hawaii

Honolulu

Cancer Research Center of Hawaii

Clinical Trials Office - Cancer Research Center of Hawaii
Ph: 808-586-2979

Idaho

Boise

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Eugenia Chang
Ph: 208-381-2731

Illinois

Chicago

Children's Memorial Hospital - Chicago

Stewart Goldman
Ph: 773-880-3270

University of Chicago Cancer Research Center

Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424

University of Illinois Cancer Center

Clinical Trial Office - University of Illinois Cancer Center
Ph: 312-355-3046

Peoria

Saint Jude Midwest Affiliate

Stephen Smith
Ph: 309-624-4945

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

Kentucky

Louisville

Kosair Children's Hospital

Clinical Trials Office - Kosair Children's Hospital
Ph: 502-629-5500

Email: CancerResource@nortonhealthcare.org

Louisiana

New Orleans

Children's Hospital of New Orleans

Clinical Trials Office - Children's Hospital of New Orleans
Ph: 504-894-5377

Michigan

Flint

Hurley Medical Center

Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057

Grand Rapids

Butterworth Hospital at Spectrum Health

David Dickens
Ph: 616-391-2086

Kalamazoo

CCOP - Kalamazoo

Jeffrey Lobel
Ph: 269-341-6350

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

CCOP - Nevada Cancer Research Foundation

Jonathan Bernstein
Ph: 702-732-0971

Jonathan Bernstein
Ph: 702-732-1493

New Jersey

Hackensack

Hackensack University Medical Center Cancer Center

Clinical Trials Office - Hackensack University Medical Center Cancer Center
Ph: 201-996-2879

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

Albany

Albany Medical Center Hospital

Vikramjit Kanwar
Ph: 518-262-5513x25265

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

Valhalla

New York Medical College

Fevzi Ozkaynak
Ph: 914-493-7997

North Carolina

Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884

Presbyterian Cancer Center at Presbyterian Hospital

Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369

Durham

Duke Comprehensive Cancer Center

Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853

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: 513-636-2799

Cleveland

Cleveland Clinic Taussig Cancer Center

Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100

Rainbow Babies and Children's Hospital

Yousif (Joe) Matloub
Ph: 216-844-3345

Columbus

Nationwide Children's Hospital

Amanda Termuhlen
Ph: 614-722-3552

Oklahoma

Oklahoma City

Oklahoma University Cancer Institute

Rene McNall-Knapp
Ph: 405-271-5311

Oregon

Portland

Knight Cancer Institute at Oregon Health and Science University

Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University
Ph: 503-494-1080

Email: trials@ohsu.edu

Legacy Emanuel Hospital and Health Center and Children's Hospital

Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital
Ph: 503-413-8199

Pennsylvania

Bethlehem

Lehigh Valley Hospital - Muhlenberg

Philip Monteleone
Ph: 484-884-3333

Danville

Geisinger Cancer Institute at Geisinger Health

Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251

Philadelphia

Children's Hospital of Philadelphia

Richard Aplenc
Ph: 267-426-7252

Pittsburgh

Children's Hospital of Pittsburgh

Clinical Trials Office - Children's Hospital of Pittsburgh
Ph: 412-692-5573

South Dakota

Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367

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

Fort Worth

Cook Children's Medical Center - Fort Worth

Clinical Trials Office - Cook's Children's Medical Center
Ph: 682-885-2103

San Antonio

Methodist Children's Hospital of South Texas

Michael Grimley
Ph: 210-575-7268

University of Texas Health Science Center at San Antonio

Paul Thomas
Ph: 210-704-2187

Virginia

Norfolk

Children's Hospital of The King's Daughters

Eric Lowe
Ph: 757-668-7243

Washington

Seattle

Children's Hospital and Regional Medical Center - Seattle

Julie Park
Ph: 206-987-2106

Spokane

Providence Cancer Center at Sacred Heart Medical Center

Judy Felgenhauer
Ph: 509-474-2777

Wisconsin

Green Bay

St. Vincent Hospital Regional Cancer Center

Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889

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

Michael Kelly
Ph: 414-456-4170

Australia

Western Australia

Perth

Princess Margaret Hospital for Children

Catherine Cole
Ph: 011-6189340-8238

Canada

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 418-656-4141X47191

British Columbia

Vancouver

Children's & Women's Hospital of British Columbia

Mason Bond
Ph: 604-875-2322

Manitoba

Winnipeg

CancerCare Manitoba

Rochelle Yanofsky
Ph: 204-787-4163

Nova Scotia

Halifax

IWK Health Centre

Margaret Yhap
Ph: 902-470-8778

Ontario

Toronto

Hospital for Sick Children

Sylvain Baruchel
Ph: 416-813-7795

Quebec

Montreal

Hopital Sainte Justine

Yvan Samson
Ph: 418-656-4141x47191

Yvan Samson
Ph: 514-345-4969

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		2009-11-23

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.