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Study of Key Late-Occurring Complications in Childhood Cancer Survivors

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

Alternate Title

Study of Late-Occurring Complications in Childhood Cancer Survivors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Genetics, Natural history/Epidemiology Active 21 and under at diagnosis, any age at study entry NCI COG-ALTE03N1
ALTE03N1, NCT00082745

Objectives

Identify key late-occurring complications, specifically, cardiac dysfunction, myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis, and subsequent malignant neoplasm, in childhood cancer survivors.
Correlate key late-occurring complications with pathology and staging of the primary malignancy and therapeutic treatment protocol details in these patients.
Identify treatment-related and demographic risk factors by comparing patients who develop late-occurring complications (case group) vs those with the same primary malignancy who do not develop late-occurring complications (control group).
Compare the frequency of mutations or polymorphisms in specific candidate genes in both the case and control groups using constitutional DNA and RNA from both groups.
Explore the role and nature of gene-environment interaction in the development of late-occurring complications in these patients.

Entry Criteria

Disease Characteristics:

Diagnosis of primary cancer at age 21 or younger

In active follow-up by a Children's Oncology Group (COG) institution
- Date of last visit or contact by a COG institution within the past 24 months

Case group
- Development of one of the following key adverse events after initiation of prior cancer therapy:
  - Cardiac dysfunction, meeting 1 of the following criteria:
    - Symptomatic cardiac dysfunction, including current or previous diagnosis of congestive heart failure based on any of the following clinical criteria:
      - Pulmonary and/or peripheral edema
      - Dyspnea
      - Orthopnea
      - Fatigue
      - Hepatomegaly
    - Asymptomatic cardiac dysfunction
      - Ejection fraction < 40% on echocardiogram OR MUGA and/or fractional shortening < 28% on echocardiogram without clinical symptoms
  - Myocardial infarction, meeting 1 of the following criteria (closed to accrual as of 6/5/06):
    - Definite ECG changes
    - Typical, atypical, or inadequately described symptoms AND probable ECG, AND abnormal enzymes, including creatine kinase MB
    - Typical symptoms AND abnormal enzymes, including creatine kinase MB, AND ischemic ECG, non-codable ECG, or ECG not available
  - Ischemic stroke, meeting the following criteria:
    - Fixed neurological deficit lasting more than 24 hours
    - Confirmed by CT scan or MRI within 7 days of onset of symptoms
    - No subarachnoid or intracerebral hemorrhage, transient ischemic attacks, or amaurosis fugax
  - Avascular necrosis, meeting the following criteria:
    - Clinical symptoms of joint pain, joint stiffness, or decreased range of motion
    - Confirmed by plain radiographs, CT scan, MRI, or bone scan
  - Subsequent malignant neoplasm, meeting the following criteria:
    - Histologically distinct neoplasm developing in patients treated for a primary cancer
    - Confirmed by an institutional pathology report

Control group
- No clinical evidence of any of the following:
  - Cardiac dysfunction
  - Myocardial infarction (closed to accrual as of 6/5/06)
  - Ischemic stroke
  - Avascular necrosis
  - Subsequent malignant neoplasm

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No prior allogeneic (non-autologous) hematopoietic cell transplant

Patient Characteristics:

Age

21 and under at diagnosis, any age at study entry

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

See Disease Characteristics

Expected Enrollment

6900

A total of 6,900 patients (1,725 with late-occurring complications [case group] and 5,175 without late-occurring complications [control group] [myocardial infarction patients closed to accrual as of 6/5/06]) will be accrued for this study.

Outline

This is a multicenter study.

DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications, such as cardiac dysfunction, myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis, and subsequent malignant neoplasms.

Patients also complete a questionnaire detailing family history and health history.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Clinical Trials Office - New Patient Services
Ph: 800-826-4673
Email: AdverseEventsStudy@coh.org

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

Downey

Southern California Permanente Medical Group

Robert Cooper
Ph: 323-783-5307

Duarte

City of Hope Comprehensive Cancer Center

Clinical Trials Office - City of Hope Comprehensive Cancer Center
Ph: 800-826-4673

Email: becomingapatient@coh.org

Los Angeles

Childrens Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-2529

Jonsson Comprehensive Cancer Center at UCLA

Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA
Ph: 888-798-0719

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Carole Hurvitz
Ph: 310-423-4423

Oakland

Children's Hospital and Research Center Oakland

Clinical Trial Office - Children's Hospital and Research Center Oakland
Ph: 510-450-7600

Sacramento

Kaiser Permanente Medical Center - Oakland

Vincent Kiley
Ph: 916-474-2326

San Diego

Rady Children's Hospital - San Diego

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

Stanford

Stanford Cancer Center

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

Email: cctoffice@stanford.edu

Colorado

Aurora

Children's Hospital Center for Cancer and Blood Disorders

Kelly Maloney
Ph: 720-777-6673

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

New Haven

Yale Cancer Center

Clinical Trials Office - Yale Cancer Center
Ph: 203-785-5702

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

Gainesville

University of Florida Shands Cancer Center

Clinical Trials Office - University of Florida Shands Cancer Center
Ph: 888-254-7581

Jacksonville

Nemours Children's Clinic

Eric Sandler
Ph: 904-697-3793

Miami

Baptist-South Miami Regional Cancer Program

Doured Daghistani
Ph: 305-274-1662

Miami Children's Hospital

Enrique Escalon
Ph: 305-662-8360x4960

University of Miami Sylvester Comprehensive Cancer Center - Miami

University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124

Email: Sylvester@emergingmed.com

Orlando

Nemours Children's Clinic - Orlando

Paul Gordon
Ph: 407-650-7330

Pensacola

Sacred Heart Cancer Center at Sacred Heart Hospital

Clinical Trials Office - Sacred Heart Cancer Center
Ph: 850-416-4611

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

Georgia

Atlanta

Winship Cancer Institute of Emory University

Howard Katzenstein
Ph: 404-785-0853

Augusta

MBCCOP - Medical College of Georgia Cancer Center

Colleen McDonough
Ph: 706-721-3626

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

Oak Lawn

Advocate Christ Medical Center

Sharad Salvi
Ph: 708-684-4094

Park Ridge

Advocate Lutheran General Cancer Care Center

Clinical Trials Office - Advocate Lutheran General Cancer Care Center
Ph: 847-384-3621

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

St. Vincent Indianapolis Hospital

Clinical Trials Office - St. Vincent Indianapolis Hospital
Ph: 317-338-2194

Iowa

Iowa City

Holden Comprehensive Cancer Center at University of Iowa

Cancer Information Service
Ph: 800-237-1225

Kansas

Kansas City

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709

Kentucky

Lexington

Lucille P. Markey Cancer Center at University of Kentucky

Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379

Louisville

Kosair Children's Hospital

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

Email: CancerResource@nortonhealthcare.org

Louisiana

Alexandria

Tulane Cancer Center Office of Clinical Research

Clinical Trials Office - Tulane Cancer Center
Ph: 504-988-6121

New Orleans

Children's Hospital of New Orleans

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

Massachusetts

Boston

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Suzanne Shusterman
Ph: 617-632-4901

Floating Hospital for Children at Tufts - New England Medical Center

Cynthia Kretschmar
Ph: 617-636-5535

Michigan

Ann Arbor

C.S. Mott Children's Hospital at University of Michigan Medical Center

Clinical Trials Office - C.S. Mott Children's Hospital
Ph: 1-800-865-1125

Detroit

Barbara Ann Karmanos Cancer Institute

Clinical Trials Office - Barbara Ann Karmanos Cancer Institute
Ph: 313-576-9363

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

Grosse Pointe Woods

Van Elslander Cancer Center at St. John Hospital and Medical Center

Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166

Kalamazoo

CCOP - Kalamazoo

Jeffrey Lobel
Ph: 269-341-6350

Lansing

Breslin Cancer Center at Ingham Regional Medical Center

Clinical Trials Office - Breslin Cancer Center at Ingham Regional Medical Center
Ph: 517-334-2765

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

Columbia

Ellis Fischel Cancer Center at University of Missouri - Columbia

Clinical Trial Office - Ellis Fischel Cancer Center
Ph: 573-882-7440

Kansas City

Children's Mercy Hospital

Maxine Hetherington
Ph: 816-234-3265

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

New Brunswick

Saint Peter's University Hospital

Douglas Cipkala
Ph: 732-745-6674

Newark

Newark Beth Israel Medical Center

Clinical Trials Office - Newark Beth Israel Medical Center
Ph: 973-926-3136

Paterson

St. Joseph's Hospital and Medical Center

Mary Bonilla
Ph: 973-754-3349

New Mexico

Albuquerque

University of New Mexico Cancer Center

Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972

New York

Brooklyn

Brooklyn Hospital Center

Swayamprabha Sadanandan
Ph: 718-250-6074

Buffalo

Roswell Park Cancer Institute

Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724

Mineola

Winthrop University Hospital

Contact Person
Ph: 516-663-9500

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

Memorial Sloan-Kettering Cancer Center

Peter Steinherz
Ph: 212-639-7951

Stony Brook

Stony Brook University Cancer Center

Clinical Trials Office - Stony Brook University Cancer Center
Ph: 800-862-2215

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

Chapel Hill

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Clinical Trials Office - Lineberger Comprehensive Cancer Center
Ph: 877-668-0683; 919-966-4432

Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

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

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

North Dakota

Fargo

CCOP - MeritCare Hospital

Nathan Kobrinsky
Ph: 701-234-7544

Ohio

Akron

Akron Children's Hospital

Clinical Trials Office - Akron Children's Hospital
Ph: 330-543-3193

Cincinnati

Cincinnati Children's Hospital Medical Center

Clinical Trials Office - Cincinnati Children's Hospital Medical Center
Ph: 513-636-2799

Cleveland

Rainbow Babies and Children's Hospital

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

Columbus

Nationwide Children's Hospital

Amanda Termuhlen
Ph: 614-722-3552

Dayton

Children's Medical Center - Dayton

Emmett Broxson
Ph: 937-641-3111

Oklahoma

Oklahoma City

Oklahoma University Cancer Institute

Rene McNall-Knapp
Ph: 405-271-5311

Oregon

Portland

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

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 Carolina

Columbia

Palmetto Health South Carolina Cancer Center

Clinical Trials Office - Palmetto Health South Carolina Cancer Center
Ph: 803-434-3680

Greenville

Greenville Hospital Cancer Center

Clinical Trials Office - Greenville Hospital Cancer Center
Ph: 864-241-6251

South Dakota

Sioux Falls

Sanford Cancer Center at Sanford USD Medical Center

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

Tennessee

Knoxville

East Tennessee Children's Hospital

Ray Pais
Ph: 865-541-8266

Memphis

St. Jude Children's Research Hospital

Clinical Trials Office - St. Jude Children's Research Hospital
Ph: 901-595-4644

Nashville

Vanderbilt-Ingram Cancer Center

Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Ph: 800-811-8480

Texas

Amarillo

Texas Tech University Health Sciences Center School of Medicine - Amarillo

Curtis Turner
Ph: 806-354-5434X264

Dallas

Medical City Dallas Hospital

Carl Lenarsky
Ph: 972-566-6647x4439

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

Houston

Baylor University Medical Center - Houston

Patrick Thompson
Ph: 832-824-4029

M. D. Anderson Cancer Center at University of Texas

Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas
Ph: 713-792-3245

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

Temple

CCOP - Scott and White Hospital

Arlynn Mulne
Ph: 254-724-2006

Utah

Salt Lake City

Primary Children's Medical Center

Phillip Barnette
Ph: 801-662-4700

Vermont

Burlington

Fletcher Allen Health Care - University Health Center Campus

Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990

Virginia

Falls Church

Inova Fairfax Hospital

Clinical Trials Office - Inova Fairfax Hospital
Ph: 703-208-6650

Norfolk

Children's Hospital of The King's Daughters

Eric Lowe
Ph: 757-668-7243

Richmond

Virginia Commonwealth University Massey Cancer Center

Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center
Ph: 804-628-1939

Roanoke

Carilion Medical Center for Children at Roanoke Community Hospital

Mandy Atkinson
Ph: 540-981-7376

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

West Virginia

Charleston

West Virginia University Health Sciences Center - Charleston

Allen Chauvenet
Ph: 304-388-1552

Wisconsin

Green Bay

St. Vincent Hospital Regional Cancer Center

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

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

Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Michael Kelly
Ph: 414-456-4170

Australia

Queensland

Brisbane

Royal Children's Hospital

Helen Irving
Ph: 617-3636-8671

South Australia

North Adelaide

Women's and Children's Hospital

Maria Kirby
Ph: 61881617411

Victoria

Parkville

Royal Children's Hospital

David Ashley
Ph: 61393455652

Western Australia

Perth

Princess Margaret Hospital for Children

Catherine Cole
Ph: 011-6189340-8238

Canada

Alberta

Edmonton

University of Alberta Hospital

Sunil Jayantilal` Desai
Ph: 780-407-8829

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

Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100x73464

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Silva
Ph: 613-5496666x3833

London

Children's Hospital of Western Ontario

A. Cairney
Ph: 519-685-8494

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Halton
Ph: 613-737-7600x2370

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

Regina

Allan Blair Cancer Centre at Pasqua Hospital

Mansoor Haq
Ph: 306-766-2498

Saskatoon

Saskatoon Cancer Centre at the University of Saskatchewan

Kaiser Ali
Ph: 306-655-2744

Puerto Rico

Santurce

San Jorge Children's Hospital

Luis Clavell
Ph: 787-728-1575

Switzerland

Geneva

Swiss Pediatric Oncology Group Geneva

Hulya Ozsahin
Ph: 0041223824712

Registry Information

Official Title		Key Adverse Events after Childhood Cancer

Trial Start Date		2004-03-22

Trial Completion Date		2005-03-02 (estimated)

Registered in ClinicalTrials.gov		NCT00082745

Date Submitted to PDQ		2004-03-01

Information Last Verified		2009-11-23

NCI Grant/Contract Number		CA95861

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.