Combination Chemotherapy in Treating Children With Neuroblastoma
31. juli 2014 oppdatert av: Children's Oncology Group
Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Determine whether the use of selected prognostic variables to assign treatment increases the event-free survival and overall survival in children with intermediate-risk neuroblastoma.
- Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population.
- Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen.
OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after the last chemotherapy administration and continuing until blood counts recover. Patients with favorable biology who do not achieve complete remission then undergo surgery to remove or debulk residual disease on day 84 or when blood counts recover. Patients with favorable biology who achieve partial response and surgery to the primary site is not deemed in the best interest of the patient may receive additional chemotherapy (as below) and delay surgery to the primary site after completion of chemotherapy.
Patients with unfavorable biology receive additional chemotherapy comprising cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days 84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over 15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or when blood counts recover.
Some patients may then undergo radiotherapy after surgery.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Studietype
Intervensjonell
Registrering (Faktiske)
573
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australia, 2145
- Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T2T 5C7
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute at University of Alberta
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- Children's & Women's Hospital of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Children's Health and Rehabilitation Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, NS B3J 3G9
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8S 4J9
- McMaster Children's Hospital at Hamilton Health Sciences
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London, Ontario, Canada, N6C 2V5
- Children's Hospital of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital at McGill University Health Center
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Montreal, Quebec, Canada, H3T 1C5
- Hôpital Sainte Justine
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Sainte Foy, Quebec, Canada, GIV 4G2
- Centre de Recherche du Centre Hospitalier de l'Universite Laval
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre at Pasqua Hospital
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Comprehensive Cancer Center at University of Alabama at Birmingham
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Mobile, Alabama, Forente stater, 36604
- University of South Alabama Cancer Research Institute
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Arizona
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Phoenix, Arizona, Forente stater, 85016
- Phoenix Children's Hospital
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Tucson, Arizona, Forente stater, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Downey, California, Forente stater, 90242
- Southern California Permanente Medical Group
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Duarte, California, Forente stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Forente stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Loma Linda, California, Forente stater, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, Forente stater, 90801-1428
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
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Los Angeles, California, Forente stater, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, Forente stater, 90027-0700
- Children's Hospital Los Angeles
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Los Angeles, California, Forente stater, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Madera, California, Forente stater, 93638-8762
- Children's Hospital Central California
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Oakland, California, Forente stater, 94609-1809
- Children's Hospital and Research Center - Oakland
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Orange, California, Forente stater, 92868
- Children's Hospital of Orange County
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Orange, California, Forente stater, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital at Stanford University Medical Center
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Sacramento, California, Forente stater, 95816
- Sutter Cancer Center
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Sacramento, California, Forente stater, 95817
- University of California Davis Cancer Center
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Sacramento, California, Forente stater, 95825
- Kaiser Permanente Medical Center - Sacramento
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San Diego, California, Forente stater, 92123-4282
- Children's Hospital and Health Center - San Diego
-
San Diego, California, Forente stater, 92120
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
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San Francisco, California, Forente stater, 94143
- UCSF Comprehensive Cancer Center
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Santa Barbara, California, Forente stater, 93102
- Santa Barbara Cottage Children's Hospital
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Santa Clara, California, Forente stater, 95051
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
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Travis Air Force Base, California, Forente stater, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forente stater, 80218
- Children's Hospital Cancer Center
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Connecticut
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Farmington, Connecticut, Forente stater, 06360-7106
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
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New Haven, Connecticut, Forente stater, 06520-8064
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Delaware
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Wilmington, Delaware, Forente stater, 19899
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Forente stater, 33316
- Broward General Medical Center Cancer Center
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Fort Myers, Florida, Forente stater, 33908
- Children's Hospital of Southwest Florida
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Gainesville, Florida, Forente stater, 32610-0296
- University of Florida Shands Cancer Center
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Hollywood, Florida, Forente stater, 33021
- Joe DiMaggio Children's Hospital at Memorial
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Jacksonville, Florida, Forente stater, 32207
- Nemours Children's Clinic
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Miami, Florida, Forente stater, 33155
- Miami Children's Hospital
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Miami, Florida, Forente stater, 33136
- Jackson Memorial Hospital
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Miami, Florida, Forente stater, 33176-2197
- Baptist-South Miami Regional Cancer Program
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Orlando, Florida, Forente stater, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Forente stater, 32806
- Nemours Children's Clinic - Orlando
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Pensacola, Florida, Forente stater, 32504
- Sacred Heart Children's Hospital
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St. Petersburg, Florida, Forente stater, 33701
- All Children's Hospital
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Tampa, Florida, Forente stater, 33677-4227
- St. Joseph's Children's Hospital of Tampa
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West Palm Beach, Florida, Forente stater, 33407
- Kaplan Cancer Center at St. Mary's Medical Center
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Forente stater, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Macon, Georgia, Forente stater, 31201
- Medical Center of Central Georgia
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Savannah, Georgia, Forente stater, 31405
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forente stater, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, Forente stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forente stater, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Forente stater, 83712
- St. Luke's Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Chicago, Illinois, Forente stater, 60614
- Children's Memorial Hospital - Chicago
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Chicago, Illinois, Forente stater, 60601
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forente stater, 60612
- University of Illinois at Chicago Cancer Center
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Oak Lawn, Illinois, Forente stater, 60453
- Advocate Hope Children's Hospital
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Park Ridge, Illinois, Forente stater, 60068-1174
- Lutheran General Cancer Care Center
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Peoria, Illinois, Forente stater, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, Forente stater, 62794-9658
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
- St. Vincent Indianapolis Hospital
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Indianapolis, Indiana, Forente stater, 46202-5225
- Riley's Children Cancer Center at Riley Hospital for Children
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Iowa
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Des Moines, Iowa, Forente stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forente stater, 50308
- Blank Children's Hospital
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kansas
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Wichita, Kansas, Forente stater, 67214
- Wesley Medical Center
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Kentucky
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Lexington, Kentucky, Forente stater, 40536-0284
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisville, Kentucky, Forente stater, 40202-3830
- Kosair Children's Hospital
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Louisiana
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New Orleans, Louisiana, Forente stater, 70118
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forente stater, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Forente stater, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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New Orleans, Louisiana, Forente stater, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Maine
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Bangor, Maine, Forente stater, 04401
- Pediatric Specialty Clinic at Eastern Maine Medical Center
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Scarborough, Maine, Forente stater, 04074-9308
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, Forente stater, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, Forente stater, 21201-1595
- Greenebaum Cancer Center at University of Maryland Medical Center
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Baltimore, Maryland, Forente stater, 21231-7223
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Silver Spring, Maryland, Forente stater, 20910
- Walter Reed Army Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forente stater, 02111
- Floating Hospital for Children
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Springfield, Massachusetts, Forente stater, 01107
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
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Worcester, Massachusetts, Forente stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109-0914
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Detroit, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, Forente stater, 49503
- DeVos Children's Hospital
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Kalamazoo, Michigan, Forente stater, 49007-5364
- Bronson Methodist Hospital
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Lansing, Michigan, Forente stater, 48910
- Breslin Cancer Center at Ingham Regional Medical Center
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Royal Oak, Michigan, Forente stater, 48073-6769
- CCOP - Beaumont
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Royal Oak, Michigan, Forente stater, 48073-6769
- William Beaumont Hospital - Royal Oak Campus
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Minneapolis, Minnesota, Forente stater, 55404
- Children's Hospitals and Clinics - Minneapolis/St. Paul
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Forente stater, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, Forente stater, 65203
- University of Missouri - Columbia
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Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forente stater, 63110
- St. Louis Children's Hospital
-
Saint Louis, Missouri, Forente stater, 63104
- Cardinal Glennon Children's Hospital
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Children's Hospital of Omaha
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Omaha, Nebraska, Forente stater, 68198-2168
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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Newark, New Jersey, Forente stater, 07112-2094
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forente stater, 07503
- St. Joseph's Hospital and Medical Center
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Summit, New Jersey, Forente stater, 07901
- Valerie Fund Children's Center at Atlantic Health
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- University of New Mexico Cancer Research and Treatment Center
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New York
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Albany, New York, Forente stater, 12208
- Children's Hospital at Albany Medical Center
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Bronx, New York, Forente stater, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Brooklyn, New York, Forente stater, 11219
- Maimonides Medical Center
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Brooklyn, New York, Forente stater, 11203
- SUNY Downstate Medical Center
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Brooklyn, New York, Forente stater, 11212
- Brookdale University Hospital and Medical Center
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Brooklyn, New York, Forente stater, 11201-5493
- Brooklyn Hospital Center
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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New Hyde Park, New York, Forente stater, 11040
- Schneider Children's Hospital
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forente stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Stony Brook, New York, Forente stater, 11794-8174
- Long Island Cancer Center at Stony Brook University Hospital
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University Hospital
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Valhalla, New York, Forente stater, 10595
- New York Medical College
-
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North Carolina
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Asheville, North Carolina, Forente stater, 28801
- Mission Hospitals - Memorial Campus
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Chapel Hill, North Carolina, Forente stater, 27599
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, Forente stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forente stater, 28233
- Presbyterian Cancer Center at Presbyterian Hospital
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Greenville, North Carolina, Forente stater, 27858-4354
- Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
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Winston-Salem, North Carolina, Forente stater, 27157-1081
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, Forente stater, 58103-4940
- Dakota Cancer Institute at Innovis Health - Dakota Clinic
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Ohio
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Akron, Ohio, Forente stater, 44308-1062
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forente stater, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
-
Cleveland, Ohio, Forente stater, 44106-5065
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
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Columbus, Ohio, Forente stater, 43205-2696
- Columbus Children's Hospital
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Dayton, Ohio, Forente stater, 45404
- Children's Medical Center - Dayton
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Toledo, Ohio, Forente stater, 43601
- Toledo Children's Hospital
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Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
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Youngstown, Ohio, Forente stater, 44501
- Tod Children's Hospital - Forum Health
-
-
Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Children's Hospital at Oklahoma University Medical Center
-
Tulsa, Oklahoma, Forente stater, 74136
- CCOP - Oklahoma
-
Tulsa, Oklahoma, Forente stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Portland, Oregon, Forente stater, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Forente stater, 97227
- Legacy Emanuel Hospital and Health Center & Children's Hospital
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Portland, Oregon, Forente stater, 97239-3098
- Doernbecher Children's Hospital at Oregon Health & Science University
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822-1320
- Geisinger Medical Center
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Forente stater, 19134-1095
- St. Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Children's Hospital of Pittsburgh
-
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
-
-
South Carolina
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Charleston, South Carolina, Forente stater, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Columbia, South Carolina, Forente stater, 29203
- Palmetto Health South Carolina Cancer Center
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Greenville, South Carolina, Forente stater, 29605
- Children's Hospital of Greenville Hospital System
-
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forente stater, 57105-1080
- Avera Cancer Institute
-
-
Tennessee
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Johnson City, Tennessee, Forente stater, 37614-0622
- East Tennessee State University Cancer Center at Johnson City Medical Center
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Knoxville, Tennessee, Forente stater, 37901
- East Tennessee Children's Hospital
-
Memphis, Tennessee, Forente stater, 38105
- St. Jude Children's Research Hospital
-
Nashville, Tennessee, Forente stater, 37232-6310
- Vanderbilt Children's Hospital
-
-
Texas
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Amarillo, Texas, Forente stater, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
Austin, Texas, Forente stater, 78701
- Children's Hospital of Austin
-
Dallas, Texas, Forente stater, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, Forente stater, 75390-9063
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Fort Worth, Texas, Forente stater, 76104
- Cook Children's Medical Center - Fort Worth
-
Galveston, Texas, Forente stater, 77555-0209
- University of Texas Medical Branch
-
Houston, Texas, Forente stater, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
-
Houston, Texas, Forente stater, 77030
- Cancer Center at Baylor College of Medicine
-
Lackland Air Force Base, Texas, Forente stater, 78236-5300
- Wilford Hall Medical Center
-
Lubbock, Texas, Forente stater, 79410
- Covenant Children's Hospital
-
San Antonio, Texas, Forente stater, 78207
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, Forente stater, 78229-3900
- MBCCOP - South Texas Pediatrics
-
San Antonio, Texas, Forente stater, 78229-3902
- Methodist Cancer Center at Methodist Specialty and Transplant Hospital
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Temple, Texas, Forente stater, 76508
- CCOP - Scott and White Hospital
-
Temple, Texas, Forente stater, 76508
- Center for Cancer Prevention and Care at Scott and White Clinic
-
-
Utah
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Salt Lake City, Utah, Forente stater, 84112
- Huntsman Cancer Institute at University of Utah
-
-
Vermont
-
Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center at University of Vermont
-
-
Virginia
-
Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, Forente stater, 22042-3300
- INOVA Fairfax Hospital
-
Norfolk, Virginia, Forente stater, 23507
- Children's Hospital of The King's Daughters
-
Portsmouth, Virginia, Forente stater, 23708-5100
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, Forente stater, 23298-0121
- Massey Cancer Center at Virginia Commonwealth University
-
Roanoke, Virginia, Forente stater, 24029
- Carilion Medical Center for Children at Roanoke Community Hospital
-
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Washington
-
Seattle, Washington, Forente stater, 98105
- Children's Hospital and Regional Medical Center - Seattle
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, Forente stater, 98112
- Group Health Central Hospital
-
Spokane, Washington, Forente stater, 99210-0248
- Deaconess Medical Center
-
Tacoma, Washington, Forente stater, 98415-0299
- Mary Bridge Children's Hospital and Health Center - Tacoma
-
Tacoma, Washington, Forente stater, 98431-0001
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Forente stater, 25302
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
-
Huntington, West Virginia, Forente stater, 25701
- Cabell Huntington Hospital
-
Morgantown, West Virginia, Forente stater, 26506-9300
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
-
Wisconsin
-
Green Bay, Wisconsin, Forente stater, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Green Bay, Wisconsin, Forente stater, 54301
- Bellin Memorial Hospital
-
Green Bay, Wisconsin, Forente stater, 54307-9070
- St. Vincent Hospital
-
La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
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Madison, Wisconsin, Forente stater, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Forente stater, 54449
- CCOP - Marshfield Clinic Research Foundation
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Marshfield, Wisconsin, Forente stater, 54449-5772
- Marshfield Clinic - Marshfield Center
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Milwaukee, Wisconsin, Forente stater, 53226
- Midwest Children's Cancer Center
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Groningen, Nederland, 9700 RB
- University Medical Center Groningen
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Auckland, New Zealand
- Starship Children's Health
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San Juan, Puerto Rico, 00936-5067
- Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
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Santurce, Puerto Rico, 00912
- San Jorge Children's Hospital
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Bern, Sveits, CH 3010
- Swiss Pediatric Oncology Group Bern
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Geneva, Sveits, CH 1211
- Swiss Pediatric Oncology Group Geneva
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Lausanne, Sveits, CH 1011
- Swiss Pediatric Oncology Group Lausanne
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 20 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically proven neuroblastoma or maturing ganglioneuroma that is judged to be intermediate risk by one of the following criteria:
International Neuroblastoma Staging System (INSS) stage III
- Under 1 year old, MYCN oncogene nonamplified, and any ploidy
- 1 to 20 years old, MYCN nonamplified, favorable Shimada histology
INSS stage IV
- Under 1 year old, MYCN nonamplified, any ploidy
INSS stage IVS
- Under 1 year old, MYCN nonamplified, unfavorable Shimada histology and any ploidy OR favorable Shimada histology and diploidy
- All patients must be registered on the companion neuroblastoma biology study (COG-ANBL00B1)
PATIENT CHARACTERISTICS:
Age:
- Under 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No abnormal organ function that would prohibit chemotherapy unless due to neuroblastoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy for patients with intradural extension and emergent paresis allowed provided biopsy was performed within 96 hours after treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other prior therapy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Behandling
Se detaljert beskrivelse.
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Andre navn:
Andre navn:
Andre navn:
Andre navn:
Andre navn:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
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Eventfri overlevelse
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Dubois SG, Geier E, Batra V, Yee SW, Neuhaus J, Segal M, Martinez D, Pawel B, Yanik G, Naranjo A, London WB, Kreissman S, Baker D, Attiyeh E, Hogarty MD, Maris JM, Giacomini K, Matthay KK. Evaluation of Norepinephrine Transporter Expression and Metaiodobenzylguanidine Avidity in Neuroblastoma: A Report from the Children's Oncology Group. Int J Mol Imaging. 2012;2012:250834. doi: 10.1155/2012/250834. Epub 2012 Sep 25.
- Marachelian A, Shimada H, Sano H, Jackson H, Stein J, Sposto R, Matthay KK, Baker D, Villablanca JG. The significance of serial histopathology in a residual mass for outcome of intermediate risk stage 3 neuroblastoma. Pediatr Blood Cancer. 2012 May;58(5):675-81. doi: 10.1002/pbc.23250.
- Meany HJ, Attiyeh EF, Naranjo A, et al.: Outcome analysis of non-high-risk neuroblastoma patients enrolled on Children's Oncology Group trials P9641 and A3961. [Abstract] J Clin Oncol 30 (Suppl 15): A-9533, 2012.
- Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007.
- Baker DL, Schmidt ML, Cohn SL, Maris JM, London WB, Buxton A, Stram D, Castleberry RP, Shimada H, Sandler A, Shamberger RC, Look AT, Reynolds CP, Seeger RC, Matthay KK; Children's Oncology Group. Outcome after reduced chemotherapy for intermediate-risk neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1313-23. doi: 10.1056/NEJMoa1001527.
- Baker DL, Schmidt M, Cohn S, et al.: A phase III trial of biologically-based therapy reduction for intermediate risk neuroblastoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-9504, 2007.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 1988
Primær fullføring (Faktiske)
1. september 2006
Studiet fullført (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først innsendt
1. november 1999
Først innsendt som oppfylte QC-kriteriene
26. januar 2003
Først lagt ut (Anslag)
27. januar 2003
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer, kjertel og epitel
- Neoplasmer, Neuroepithelial
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Neuroektodermale svulster, primitive
- Neuroektodermale svulster, primitive, perifere
- Nevroblastom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Adjuvanser, immunologiske
- Antibiotika, antineoplastisk
- Cyklofosfamid
- Karboplatin
- Etoposid
- Lenograstim
- Doxorubicin
- Liposomal doksorubicin
- Sargramostim
- Molgramostim
Andre studie-ID-numre
- A3961
- COG-A3961 (Annen identifikator: Children's Oncology Group)
- CCG-A3961 (Annen identifikator: Children's Cancer Group)
- POG-A3961 (Annen identifikator: Pediatric Oncology Group)
- CDR0000065804 (Annen identifikator: Clinical Trials.gov)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .