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Clinical Trials (PDQ®)

Study of Late-Occurring Complications in Childhood Cancer Survivors

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/EpidemiologyActive21 and under at diagnosis, any age at study entryNCI, OtherALTE03N1
NCI-2011-03822, COG-ALTE03N1, CDR0000360708, U10CA095861, NCT00082745

Trial Description

Summary

This clinical trial is studying cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Further Study Information

PRIMARY OBJECTIVES:

I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional DNA and RNA from the cases and controls.

V. To explore the role and nature of gene-environment interaction in the development of key adverse events.

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 (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasms.

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

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:
  • Cardiac dysfunction; Please Note: case enrollment has been closed due to achievement of target accrual
  • Ischemic stroke (IS)
  • Subsequent malignant neoplasm (SMN)
  • Avascular necrosis (AVN); Please Note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements; Please Note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian, obtained in accordance with institutional policies approved by the U.S. Department of Health and Human Services
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; Please Note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required

Trial Contact Information

Trial Lead Organizations/Sponsors

Children's Oncology Group

National Cancer Institute

Smita Bhatia, MD MPHPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 Children's Hospital of Alabama at University of Alabama at Birmingham
 Alyssa T Reddy Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Alyssa T Reddy Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Children's Hospital at the University of Arkansas for Medical Sciences
 David L Becton Ph: 501-364-7373
California
  Downey
 Southern California Permanente Medical Group
 Robert M Cooper Ph: 626-564-3455
  Duarte
 City of Hope Comprehensive Cancer Center
 Smita Bhatia Ph: 800-826-4673
  Email: becomingapatient@coh.org
 Smita Bhatia
  Los Angeles
 Children's Hospital Los Angeles
 Leo Mascarenhas Ph: 323-361-4110
 Jonsson Comprehensive Cancer Center at UCLA
 Pamela H Kempert Ph: 310-825-6708
 Mattel Children's Hospital at UCLA
 Pamela H Kempert Ph: 310-825-6708
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Fataneh (Fae) Majlessipour Ph: 310-423-8965
  Oakland
 Children's Hospital and Research Center Oakland
 Carla B Golden Ph: 510-450-7600
 Kaiser Permanente-Oakland
 Steven K Bergstrom Ph: 626-564-3455
  Palo Alto
 Lucile Packard Children's Hospital at Stanford University Medical Center
 Neyssa M Marina Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  San Diego
 Rady Children's Hospital - San Diego
 William D Roberts Ph: 858-966-5934
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Kelly W Maloney Ph: 720-777-6672
Connecticut
  Hartford
 Connecticut Children's Medical Center
 Michael S Isakoff Ph: 860-545-9981
  New Haven
 Yale Cancer Center
 Nina S Kadan-Lottick Ph: 203-785-5702
Delaware
  Wilmington
 Alfred I. duPont Hospital for Children
 Christopher N Frantz Ph: 302-651-5755
District of Columbia
  Washington
 Children's National Medical Center
 Jeffrey S Dome Ph: 202-884-2549
Florida
  Fort Myers
 Children's Hospital of Southwest Florida
 Emad K Salman Ph: 239-343-5333
  Gainesville
 UF Health Cancer Center
 William B Slayton Ph: 352-273-8675
  Email: trials@cancer.ufl.edu
  Jacksonville
 Nemours Children's Clinic
 Scott M Bradfield Ph: 904-697-3529
  Miami
 Baptist-South Miami Regional Cancer Program
 Doured Daghistani Ph: 800-599-2456
  Email: cancerinfo@baptisthealth.net
 Miami Children's Hospital
 Enrique A Escalon Ph: 305-662-8360
  Orlando
 Nemours Children's Hospital
 Ramamoorthy Nagasubramanian Ph: 407-650-7150
  Pensacola
 Nemours Children's Clinic - Pensacola
 Jeffrey H Schwartz Ph: 904-697-3529
  Saint Petersburg
 All Children's Hospital
 Gregory A Hale Ph: 727-767-2423
  Email: HamblinF@allkids.org
  Tampa
 St. Joseph's Children's Hospital of Tampa
 Hardeo K Panchoosingh Ph: 800-882-4123
Georgia
  Atlanta
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 Glen Lew Ph: 404-785-1112
  Augusta
 Medical College of Georgia Cancer Center
 Colleen H McDonough Ph: 706-721-1663
  Email: cancer@georgiahealth.edu
Hawaii
  Honolulu
 Cancer Research Center of Hawaii
 Robert W Wilkinson Ph: 808-983-6090
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Eugenia Chang Ph: 800-845-4624
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 David O Walterhouse Ph: 773-880-4562
 University of Chicago Cancer Research Center
 Susan L Cohn Ph: 773-834-7424
 University of Illinois Cancer Center
 Mary L Schmidt Ph: 312-355-3046
  Oak Lawn
 Keyser Family Cancer Center at Advocate Hope Children's Hospital
 Ammar Hayani Ph: 800-323-8622
  Park Ridge
 Advocate Lutheran General Cancer Care Center
 Jong-Hyo Kwon Ph: 847-384-3621
  Peoria
 Saint Jude Midwest Affiliate
 Karen S Fernandez Ph: 309-655-3258
Indiana
  Indianapolis
 Riley's Children Cancer Center at Riley Hospital for Children
 Robert J Fallon Ph: 317-274-2552
 St. Vincent Indianapolis Hospital
 Bassem I Razzouk Ph: 317-338-2194
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Ayman A El-Sheikh Ph: 800-237-1225
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Smita Bhatia
Kentucky
  Lexington
 University of Kentucky Chandler Medical Center
 Martha F Greenwood Ph: 859-257-3379
  Louisville
 Kosair Children's Hospital
 Kenneth G Lucas Ph: 866-530-5516
  Email: CTO@hmc.psu.edu
Louisiana
  New Orleans
 Children's Hospital of New Orleans
 Smita Bhatia
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Carlos Rodriguez-Galindo Ph: 866-790-4500
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Raymond J Hutchinson Ph: 800-865-1125
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Hadi Sawaf Ph: 313-343-3166
 Wayne State University
 Smita Bhatia
  East Lansing
 Breslin Cancer Center at Ingham Regional Medical Center
 Renuka Gera Ph: 517-975-9547
  Flint
 Hurley Medical Center
 Susumu Inoue Ph: 888-606-6556
  Grand Rapids
 Helen DeVos Children's Hospital at Spectrum Health
 David S Dickens Ph: 616-267-1925
  Kalamazoo
 Bronson Methodist Hospital
 Jeffrey S Lobel Ph: 800-227-2345
 Western Michigan University School of Medicine Clinics
 Jeffrey S Lobel Ph: 800-227-2345
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C Bostrom Ph: 612-813-5193
 Masonic Cancer Center at University of Minnesota
 Joseph P Neglia Ph: 612-624-2620
  Rochester
 Mayo Clinic Cancer Center
 Carola A. S. Arndt Ph: 507-538-7623
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail C Megason Ph: 601-815-6700
Missouri
  Columbia
 Columbia Regional Hospital
 Thomas W Loew Ph: 573-882-7440
  Kansas City
 Children's Mercy Hospital
 Maxine L Hetherington Ph: 816-234-3265
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert J Hayashi Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 Nik Farahana N Rashid Ph: 702-384-0013
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Michael B Harris Ph: 201-996-2879
  Livingston
 St. Barnabas Medical Center Cancer Center
 Smita Bhatia
  New Brunswick
 Saint Peter's University Hospital
 Stanley Calderwood Ph: 732-745-8600ext6163
  Email: kcovert@saintpetersuh.com
  Newark
 Newark Beth Israel Medical Center
 Peri Kamalakar Ph: 973-926-7230
  Paterson
 St. Joseph's Hospital and Medical Center
 Mary A Bonilla Ph: 973-754-2909
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Koh B Boayue Ph: 505-272-6972
 Smita Bhatia
New York
  Brooklyn
 Maimonides Cancer Center at Maimonides Medical Center
 Smita Bhatia
  Buffalo
 Roswell Park Cancer Institute
 Martin L Brecher Ph: 877-275-7724
  Mineola
 Winthrop University Hospital
 Mark E Weinblatt Ph: 866-946-8476
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Alice Lee Ph: 212-305-8615
 Memorial Sloan-Kettering Cancer Center
 Peter G Steinherz Ph: 212-639-7202
  Stony Brook
 Stony Brook University Cancer Center
 Robert I Parker Ph: 800-862-2215
  Syracuse
 SUNY Upstate Medical University Hospital
 Karol H Kerr Ph: 315-464-5476
  Valhalla
 New York Medical College
 Jessica C Hochberg Ph: 914-594-3794
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Stuart H Gold Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Durham
 Duke Cancer Institute
 Susan G Kreissman Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Thomas W McLean Ph: 336-713-6771
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Nathan L Kobrinsky Ph: 701-234-6161
Ohio
  Akron
 Akron Children's Hospital
 Steven J Kuerbitz Ph: 330-543-3193
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 John P Perentesis Ph: 513-636-2799
  Cleveland
 Seidman Cancer Center at University Hospitals/Case Medical Center
 Yousif (Joe) H Matloub Ph: 216-844-5437
  Columbus
 Nationwide Children's Hospital
 Mark A Ranalli Ph: 614-722-2708
  Dayton
 Dayton Children's - Dayton
 Emmett H Broxson Ph: 800-228-4055
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene Y McNall-Knapp Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Portland
 Legacy Emanuel Children's Hospital
 Janice F Olson Ph: 503-413-2560
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Janice F Olson Ph: 503-413-2560
Pennsylvania
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Philip M Monteleone Ph: 484-884-2201
  Philadelphia
 Children's Oncology Group
 Smita Bhatia Ph: 626-471-7321
  Email: sbhatia@coh.org
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 Arthur K Ritchey Ph: 412-692-5573
PR
  San Juan
 San Jorge Children's Hospital
 Luis A Clavell Ph: 888-823-5923
  Email: ctsucontact@westat.com
South Carolina
  Columbia
 Palmetto Health South Carolina Cancer Center
 Ronnie W. Neuberg Ph: 803-434-3680
  Greenville
 BI-LO Charities Children's Cancer Center
 Nichole L Bryant Ph: 864-241-6251
 Cancer Centers of the Carolinas - Faris Road
 Cary E Stroud Ph: 864-241-6251
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Kayelyn J Wagner Ph: 605-328-1367
Tennessee
  Johnson City
 East Tennessee State University Cancer Center at Johnson City Medical Center
 Smita Bhatia
  Knoxville
 East Tennessee Children's Hospital
 Ray C Pais Ph: 865-541-8266
  Memphis
 St. Jude Children's Research Hospital
 Wayne L Furman Ph: 901-595-4644
  Nashville
 Vanderbilt-Ingram Cancer Center
 Debra L Friedman Ph: 800-811-8480
Texas
  Corpus Christi
 Driscoll Children's Hospital
 M. C Johnson Ph: 361-694-5311
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky Ph: 972-566-5588
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Naomi J Winick Ph: 214-648-7097
  Fort Worth
 Cook Children's Medical Center - Fort Worth
 Mary Meaghan P Granger Ph: 682-885-2103
  Houston
 Dan L. Duncan Cancer Center at Baylor College of Medicine
 Karen R Rabin Ph: 713-798-1354
  Email: burton@bcm.edu
  San Antonio
 Methodist Children's Hospital of South Texas
 Jaime Estrada Ph: 210-575-7000
 University of Texas Health Science Center at San Antonio
 Anne-Marie R Langevin Ph: 210-567-0653
  Email: che@uthscsa.edu
  Temple
 Scott and White Cancer Institute
 Guy H Grayson Ph: 254-724-5407
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip E Barnette Ph: 801-585-5270
Virginia
  Falls Church
 Inova Fairfax Hospital
 Marshall A Schorin Ph: 703-208-6650
  Norfolk
 Children's Hospital of The King's Daughters
 Eric J Lowe Ph: 757-668-7243
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Madhu S Gowda Ph: 804-628-1939
  Roanoke
 Carilion Medical Center for Children at Roanoke Community Hospital
 Mandy M Atkinson Ph: 540-981-7376
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 K. S Baker Ph: 800-422-6237
  Spokane
 Providence Cancer Center at Sacred Heart Medical Center
 Judy L Felgenhauer Ph: 800-228-6618
  Email: HopeBeginsHere@providence.org
West Virginia
  Charleston
 West Virginia University Medical School - Charleston
 Howard M Grodman Ph: 304-388-9944
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 John R Hill Ph: 920-433-8889
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Kenneth B DeSantes Ph: 608-262-5223
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael E Kelly Ph: 414-805-4380
Australia
Queensland
  Herston
 Royal Brisbane and Women's Hospital
 Helen Irving Ph: 888-823-5923
  Email: ctsucontact@westat.com
 Royal Children's Hospital
 Helen Irving Ph: 888-823-5923
  Email: ctsucontact@westat.com
South Australia
  North Adelaide
 Women's and Children's Hospital
 Maria L Kirby Ph: (08) 8161 7327
  Email: cywhs.oncsec@health.sa.gov.au
Victoria
  Parkville
 Royal Children's Hospital
 John A Heath
  Email: crdo.info@mcri.edu.au
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine H Cole Ph: (08) 9340 8330
  Email: admin@childcancerresearch.com.au
Canada
Alberta
  Edmonton
 University of Alberta Hospital
 Sunil Jayantilal S Desai Ph: 780-407-6615
  Email: val.taylor@albertahealthservices.ca
British Columbia
  Vancouver
 Children's and Women's Hospital of British Columbia
 Caron Strahlendorf Ph: 604-875-2345ext6477
Manitoba
  Winnipeg
 CancerCare Manitoba
 Rochelle A Yanofsky Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca
Nova Scotia
  Halifax
 IWK Health Centre
 Margaret C Yhap Ph: 902-470-8394
Ontario
  Hamilton
 McMaster Children's Hospital at Hamilton Health Sciences
 Carol Portwine Ph: 905-521-2100ext74595
 Carol Portwine Ph: 905-521-2100ext74595
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Mariana P Silva Ph: 613-544-2630
  London
 Children's Hospital of Western Ontario
 Anne E Cairney Ph: 519-685-8306
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline M Halton Ph: 613-738-3931
  Toronto
 Hospital for Sick Children
 Sarah W Alexander Ph: 416-813-7654ext2027
  Email: jason.mcguire@sickkids.ca
Quebec
  Montreal
 Hopital Sainte Justine
 Yvan Samson Ph: 514-345-4931
 Montreal Children's Hospital at McGill University Health Center
 Smita Bhatia
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Christopher Mpofu Ph: 306-655-2914
Switzerland
  Geneva
 Swiss Pediatric Oncology Group Geneva
 Marc Ansari Ph:  031 389 91 89

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00082745
ClinicalTrials.gov processed this data on February 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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