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Last Modified: 2/5/2010     First Published: 12/22/2005  
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Phase III Study of Radiotherapy and Amifostine OR Neoadjuvant Induction Chemotherapy Followed By Consolidation Chemoradiotherapy and Amifostine in Children With Newly Diagnosed Nasopharyngeal Carcinoma

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

Alternate Title

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and underNCICOG-ARAR0331
ARAR0331, NCT00274937

Objectives

Primary

  1. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine.

Secondary

  1. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
  2. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.
  3. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.
  4. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy.

Entry Criteria

Disease Characteristics:

  • Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
    • Stage I-IV disease
    • Newly diagnosed disease

Prior/Concurrent Therapy:

  • No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma

Patient Characteristics:

  • Performance status
    • Patients ≤ 16 years of age: Lansky 60-100%
    • Patients > 16 years of age: Karnofsky 60-100%
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min

    OR

  • Creatinine based on age/gender as follows:
    • No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age)
    • No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age)
    • No greater than 0.6 mg/dL (for patients 1-2 years of age)
    • No greater than 0.8 mg/dL (for patients < 6 years of age)
    • No greater than 1.0 mg/dL (for patients 6 to < 10 years of age)
    • No greater than 1.2 mg/dL (for patients 10 to < 13 years of age)
    • No greater than 1.4 mg/dL (for female patients 13 to ≥ 16 years of age)
    • No greater than 1.5 mg/dL (for male patients 13 to < 16 years of age)
    • No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Expected Enrollment

111

A total of 160 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Disease-free survival at 2 years after treatment
Response rate at 12 weeks after induction

Secondary Outcome(s)

Predictive value of Epstein-Barr virus (EBV) DNA as measured by quantitative detection at 2 years after treatment

Outline

This is a nonrandomized, multicenter study. Patients are stratified according to stage of disease (I or IIA [stratum I] vs IIB-IV [stratum II]).

  • Stratum I: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.

  • Stratum II:
    • Induction therapy (weeks 1-9): Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease proceed to consolidation therapy.

    • Consolidation therapy (weeks 10-18): Patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive cisplatin IV over 6 hours on days 1 and 22 (2 courses).

After completion of study treatment, patients are followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Carlos Rodriguez-Galindo, MD, Protocol chair
Ph: 901-595-2203
Email: Carlos.Rodriguez-Galindo@stjude.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
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas
Ph: 323-361-2529
  Madera
 Children's Hospital Central California
 Vonda Crouse
Ph: 559-353-5480
  Sacramento
 Kaiser Permanente Medical Center - Oakland
 Vincent Kiley
Ph: 916-474-2326
  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
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
District of Columbia
  Washington
 Walter Reed Army Medical Center
 Clinical Trials Office - Walter Reed Army Medical Center
Ph: 202-782-7840
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
  Hollywood
 Memorial Cancer Institute at Memorial Regional Hospital
 Clinical Trials Office - Memorial Cancer Institute
Ph: 954-985-3443
  Miami
 Miami Children's Hospital
 Enrique Escalon
Ph: 305-662-8360x4960
  Saint 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
Illinois
  Chicago
 Children's Memorial Hospital - Chicago
 Stewart Goldman
Ph: 773-880-3270
  Springfield
 Simmons Cooper Cancer Institute
 Clinical Trials Office - Simmons Cooper Cancer Institute
Ph: 217-545-7929
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
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
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Joseph Wiley
Ph: 410-601-5864
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Ph: 410-955-8804
 Email: jhcccro@jhmi.edu
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
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 David Dickens
Ph: 616-391-2086
Minnesota
  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
  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
Nebraska
  Omaha
 Children's Hospital
 Minnie Abromowitch
Ph: 402-955-3950
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 Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Newark
 Newark Beth Israel Medical Center
 Clinical Trials Office - Newark Beth Israel Medical Center
Ph: 973-926-3136
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Lisa Hackney
Ph: 585-275-2981
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
 Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center
Ph: 704-355-2884
North Dakota
  Fargo
 CCOP - MeritCare Hospital
 Nathan Kobrinsky
Ph: 701-234-7544
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
  Dayton
 Children's Medical Center - Dayton
 Emmett Broxson
Ph: 937-641-3111
  Toledo
 Medical University of Ohio Cancer Center
 Clinical Trials Office - Medical University of Ohio Cancer Center
Ph: 419-383-6583
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Rene McNall-Knapp
Ph: 405-271-5311
Pennsylvania
  Hershey
 Penn State Cancer Institute at Milton S. Hershey Medical Center
 Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center
Ph: 717-531-3779
 Email: CTO@hmc.psu.edu
  Philadelphia
 Children's Hospital of Philadelphia
 Richard Aplenc
Ph: 267-426-7252
 St. Christopher's Hospital for Children
 Clinical Trials Office - St. Christopher's Hospital for Children
Ph: 215-427-8991
  Pittsburgh
 Children's Hospital of Pittsburgh
 Clinical Trials Office - Children's Hospital of Pittsburgh
Ph: 412-692-7056
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
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
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
  Houston
 Baylor University Medical Center - Houston
 Patrick Thompson
Ph: 832-824-4029
  San Antonio
 Methodist Children's Hospital of South Texas
 Michael Grimley
Ph: 210-575-7268
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip Barnette
Ph: 801-662-4700
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
Washington
  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
  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
Alberta
  Calgary
 Alberta Children's Hospital
 Douglas Strother
Ph: 403-943-7211
 Douglas Strother
Ph: 403-955-7272
British Columbia
  Vancouver
 Children's & Women's Hospital of British Columbia
 Mason Bond
Ph: 604-875-2322
Nova Scotia
  Halifax
 IWK Health Centre
 Margaret Yhap
Ph: 902-470-8778
Ontario
  Ottawa
 Children's Hospital of Eastern Ontario
 Jacqueline Halton
Ph: 613-737-7600x2370
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
 Christopher Mpofu
Ph: 306-655-2744

Registry Information
Official Title Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy
Trial Start Date 2006-02-20
Trial Completion Date 2009-06-04 (estimated)
Registered in ClinicalTrials.gov NCT00274937
Date Submitted to PDQ 2005-09-15
Information Last Verified 2010-02-08
NCI Grant/Contract Number CA98543

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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