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Combination Chemotherapy in Treating Children With Neuroblastoma

31 de julio de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Neuroblastoma

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

573

Fase

Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Australia
- New South Wales
  - Randwick, New South Wales, Australia, 2031
    - Sydney Children's Hospital
  - Westmead, New South Wales, Australia, 2145
    - Children's Hospital at Westmead
- Queensland
  - Brisbane, Queensland, Australia, 4029
    - Royal Children's Hospital
- South Australia
  - North Adelaide, South Australia, Australia, 5006
    - Women's and Children's Hospital
- Victoria
  - Parkville, Victoria, Australia, 3052
    - Royal Children's Hospital
- Western Australia
  - Perth, Western Australia, Australia, 6001
    - Princess Margaret Hospital for Children
Canadá
- Alberta
  - Calgary, Alberta, Canadá, T2T 5C7
    - Alberta Children's Hospital
  - Edmonton, Alberta, Canadá, T6G 1Z2
    - Cross Cancer Institute at University of Alberta
- British Columbia
  - Vancouver, British Columbia, Canadá, V6H 3V4
    - Children's & Women's Hospital of British Columbia
- Manitoba
  - Winnipeg, Manitoba, Canadá, R3E 0V9
    - CancerCare Manitoba
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
    - Janeway Children's Health and Rehabilitation Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canadá, NS B3J 3G9
    - IWK Health Centre
- Ontario
  - Hamilton, Ontario, Canadá, L8S 4J9
    - McMaster Children's Hospital at Hamilton Health Sciences
  - London, Ontario, Canadá, N6C 2V5
    - Children's Hospital of Western Ontario
  - Ottawa, Ontario, Canadá, K1H 8L1
    - Children's Hospital of Eastern Ontario
  - Toronto, Ontario, Canadá, M5G 1X8
    - Hospital for Sick Children
- Quebec
  - Montreal, Quebec, Canadá, H3H 1P3
    - Montreal Children's Hospital at McGill University Health Center
  - Montreal, Quebec, Canadá, H3T 1C5
    - Hôpital Sainte Justine
  - Sainte Foy, Quebec, Canadá, GIV 4G2
    - Centre de Recherche du Centre Hospitalier de l'Universite Laval
- Saskatchewan
  - Regina, Saskatchewan, Canadá, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - Saskatoon, Saskatchewan, Canadá, S7N 4H4
    - Saskatoon Cancer Centre
Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos, 35233
    - Comprehensive Cancer Center at University of Alabama at Birmingham
  - Mobile, Alabama, Estados Unidos, 36604
    - University of South Alabama Cancer Research Institute
- Arizona
  - Phoenix, Arizona, Estados Unidos, 85016
    - Phoenix Children's Hospital
  - Tucson, Arizona, Estados Unidos, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, Estados Unidos, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Downey, California, Estados Unidos, 90242
    - Southern California Permanente Medical Group
  - Duarte, California, Estados Unidos, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, Estados Unidos, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Loma Linda, California, Estados Unidos, 92354
    - Loma Linda University Cancer Institute at Loma Linda University Medical Center
  - Long Beach, California, Estados Unidos, 90801-1428
    - Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  - Los Angeles, California, Estados Unidos, 90095-1781
    - Jonsson Comprehensive Cancer Center at UCLA
  - Los Angeles, California, Estados Unidos, 90027-0700
    - Children's Hospital Los Angeles
  - Los Angeles, California, Estados Unidos, 90048
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Madera, California, Estados Unidos, 93638-8762
    - Children's Hospital Central California
  - Oakland, California, Estados Unidos, 94609-1809
    - Children's Hospital and Research Center - Oakland
  - Orange, California, Estados Unidos, 92868
    - Children's Hospital of Orange County
  - Orange, California, Estados Unidos, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  - Palo Alto, California, Estados Unidos, 94304
    - Lucile Packard Children's Hospital at Stanford University Medical Center
  - Sacramento, California, Estados Unidos, 95816
    - Sutter Cancer Center
  - Sacramento, California, Estados Unidos, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, Estados Unidos, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Diego, California, Estados Unidos, 92123-4282
    - Children's Hospital and Health Center - San Diego
  - San Diego, California, Estados Unidos, 92120
    - Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
  - San Francisco, California, Estados Unidos, 94143
    - UCSF Comprehensive Cancer Center
  - Santa Barbara, California, Estados Unidos, 93102
    - Santa Barbara Cottage Children's Hospital
  - Santa Clara, California, Estados Unidos, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Travis Air Force Base, California, Estados Unidos, 94535
    - General Robert Huyser Cancer Center at David Grant Medical Center
- Colorado
  - Denver, Colorado, Estados Unidos, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, Estados Unidos, 80218
    - Children's Hospital Cancer Center
- Connecticut
  - Farmington, Connecticut, Estados Unidos, 06360-7106
    - Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  - New Haven, Connecticut, Estados Unidos, 06520-8064
    - Yale Comprehensive Cancer Center at Yale University School of Medicine
- Delaware
  - Wilmington, Delaware, Estados Unidos, 19899
    - Alfred I. DuPont Hospital for Children
- District of Columbia
  - Washington, District of Columbia, Estados Unidos, 20007
    - Lombardi Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, Estados Unidos, 20010-2970
    - Children's National Medical Center
- Florida
  - Fort Lauderdale, Florida, Estados Unidos, 33316
    - Broward General Medical Center Cancer Center
  - Fort Myers, Florida, Estados Unidos, 33908
    - Children's Hospital of Southwest Florida
  - Gainesville, Florida, Estados Unidos, 32610-0296
    - University of Florida Shands Cancer Center
  - Hollywood, Florida, Estados Unidos, 33021
    - Joe DiMaggio Children's Hospital at Memorial
  - Jacksonville, Florida, Estados Unidos, 32207
    - Nemours Children's Clinic
  - Miami, Florida, Estados Unidos, 33155
    - Miami Children's Hospital
  - Miami, Florida, Estados Unidos, 33136
    - Jackson Memorial Hospital
  - Miami, Florida, Estados Unidos, 33176-2197
    - Baptist-South Miami Regional Cancer Program
  - Orlando, Florida, Estados Unidos, 32804
    - Florida Hospital Cancer Institute
  - Orlando, Florida, Estados Unidos, 32806
    - Nemours Children's Clinic - Orlando
  - Pensacola, Florida, Estados Unidos, 32504
    - Sacred Heart Children's Hospital
  - St. Petersburg, Florida, Estados Unidos, 33701
    - All Children's Hospital
  - Tampa, Florida, Estados Unidos, 33677-4227
    - St. Joseph's Children's Hospital of Tampa
  - West Palm Beach, Florida, Estados Unidos, 33407
    - Kaplan Cancer Center at St. Mary's Medical Center
- Georgia
  - Atlanta, Georgia, Estados Unidos, 30342
    - AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
  - Augusta, Georgia, Estados Unidos, 30912-4000
    - MBCCOP-Medical College of Georgia Cancer Center
  - Macon, Georgia, Estados Unidos, 31201
    - Medical Center of Central Georgia
  - Savannah, Georgia, Estados Unidos, 31405
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Hawaii
  - Honolulu, Hawaii, Estados Unidos, 96859-5000
    - Tripler Army Medical Center
  - Honolulu, Hawaii, Estados Unidos, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Estados Unidos, 96813
    - MBCCOP - Hawaii
- Idaho
  - Boise, Idaho, Estados Unidos, 83712
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Chicago, Illinois, Estados Unidos, 60612
    - Rush University Medical Center
  - Chicago, Illinois, Estados Unidos, 60614
    - Children's Memorial Hospital - Chicago
  - Chicago, Illinois, Estados Unidos, 60601
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Estados Unidos, 60612
    - University of Illinois at Chicago Cancer Center
  - Oak Lawn, Illinois, Estados Unidos, 60453
    - Advocate Hope Children's Hospital
  - Park Ridge, Illinois, Estados Unidos, 60068-1174
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, Estados Unidos, 61637
    - Saint Jude Midwest Affiliate
  - Springfield, Illinois, Estados Unidos, 62794-9658
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Estados Unidos, 46260
    - St. Vincent Indianapolis Hospital
  - Indianapolis, Indiana, Estados Unidos, 46202-5225
    - Riley's Children Cancer Center at Riley Hospital for Children
- Iowa
  - Des Moines, Iowa, Estados Unidos, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Estados Unidos, 50308
    - Blank Children's Hospital
  - Iowa City, Iowa, Estados Unidos, 52242-1009
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Wichita, Kansas, Estados Unidos, 67214
    - Wesley Medical Center
- Kentucky
  - Lexington, Kentucky, Estados Unidos, 40536-0284
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, Estados Unidos, 40202-3830
    - Kosair Children's Hospital
- Louisiana
  - New Orleans, Louisiana, Estados Unidos, 70118
    - Children's Hospital of New Orleans
  - New Orleans, Louisiana, Estados Unidos, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, Estados Unidos, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
  - New Orleans, Louisiana, Estados Unidos, 70112
    - Tulane Cancer Center at Tulane University Hospital and Clinic
- Maine
  - Bangor, Maine, Estados Unidos, 04401
    - Pediatric Specialty Clinic at Eastern Maine Medical Center
  - Scarborough, Maine, Estados Unidos, 04074-9308
    - Maine Children's Cancer Program
- Maryland
  - Baltimore, Maryland, Estados Unidos, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
  - Baltimore, Maryland, Estados Unidos, 21201-1595
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Baltimore, Maryland, Estados Unidos, 21231-7223
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Silver Spring, Maryland, Estados Unidos, 20910
    - Walter Reed Army Medical Center
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, Estados Unidos, 02111
    - Floating Hospital for Children
  - Springfield, Massachusetts, Estados Unidos, 01107
    - Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  - Worcester, Massachusetts, Estados Unidos, 01655
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Estados Unidos, 48109-0914
    - University Of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Estados Unidos, 48201
    - Children's Hospital of Michigan
  - Detroit, Michigan, Estados Unidos, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Flint, Michigan, Estados Unidos, 48503
    - Hurley Medical Center
  - Grand Rapids, Michigan, Estados Unidos, 49503
    - DeVos Children's Hospital
  - Kalamazoo, Michigan, Estados Unidos, 49007-5364
    - Bronson Methodist Hospital
  - Lansing, Michigan, Estados Unidos, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Royal Oak, Michigan, Estados Unidos, 48073-6769
    - CCOP - Beaumont
  - Royal Oak, Michigan, Estados Unidos, 48073-6769
    - William Beaumont Hospital - Royal Oak Campus
- Minnesota
  - Duluth, Minnesota, Estados Unidos, 55805
    - St. Mary's - Duluth Clinic Cancer Center
  - Minneapolis, Minnesota, Estados Unidos, 55404
    - Children's Hospitals and Clinics - Minneapolis/St. Paul
  - Rochester, Minnesota, Estados Unidos, 55905
    - Mayo Clinic Cancer Center
- Mississippi
  - Jackson, Mississippi, Estados Unidos, 39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Columbia, Missouri, Estados Unidos, 65203
    - University of Missouri - Columbia
  - Kansas City, Missouri, Estados Unidos, 64108
    - Children's Mercy Hospital
  - Saint Louis, Missouri, Estados Unidos, 63110
    - St. Louis Children's Hospital
  - Saint Louis, Missouri, Estados Unidos, 63104
    - Cardinal Glennon Children's Hospital
- Nebraska
  - Omaha, Nebraska, Estados Unidos, 68114
    - Children's Hospital of Omaha
  - Omaha, Nebraska, Estados Unidos, 68198-2168
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, Estados Unidos, 89109
    - Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, Estados Unidos, 03756
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Hackensack, New Jersey, Estados Unidos, 07601
    - Hackensack University Medical Center
  - New Brunswick, New Jersey, Estados Unidos, 08903
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - Newark, New Jersey, Estados Unidos, 07112-2094
    - Newark Beth Israel Medical Center
  - Paterson, New Jersey, Estados Unidos, 07503
    - St. Joseph's Hospital and Medical Center
  - Summit, New Jersey, Estados Unidos, 07901
    - Valerie Fund Children's Center at Atlantic Health
- New Mexico
  - Albuquerque, New Mexico, Estados Unidos, 87131
    - University of New Mexico Cancer Research and Treatment Center
- New York
  - Albany, New York, Estados Unidos, 12208
    - Children's Hospital at Albany Medical Center
  - Bronx, New York, Estados Unidos, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Brooklyn, New York, Estados Unidos, 11219
    - Maimonides Medical Center
  - Brooklyn, New York, Estados Unidos, 11203
    - SUNY Downstate Medical Center
  - Brooklyn, New York, Estados Unidos, 11212
    - Brookdale University Hospital and Medical Center
  - Brooklyn, New York, Estados Unidos, 11201-5493
    - Brooklyn Hospital Center
  - Buffalo, New York, Estados Unidos, 14263-0001
    - Roswell Park Cancer Institute
  - New Hyde Park, New York, Estados Unidos, 11040
    - Schneider Children's Hospital
  - New York, New York, Estados Unidos, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Estados Unidos, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, Estados Unidos, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - New York, New York, Estados Unidos, 10029
    - Mount Sinai Medical Center
  - Rochester, New York, Estados Unidos, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Stony Brook, New York, Estados Unidos, 11794-8174
    - Long Island Cancer Center at Stony Brook University Hospital
  - Syracuse, New York, Estados Unidos, 13210
    - SUNY Upstate Medical University Hospital
  - Valhalla, New York, Estados Unidos, 10595
    - New York Medical College
- North Carolina
  - Asheville, North Carolina, Estados Unidos, 28801
    - Mission Hospitals - Memorial Campus
  - Chapel Hill, North Carolina, Estados Unidos, 27599
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, Estados Unidos, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Charlotte, North Carolina, Estados Unidos, 28233
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Durham, North Carolina, Estados Unidos, 27710
    - Duke Comprehensive Cancer Center
  - Greenville, North Carolina, Estados Unidos, 27858-4354
    - Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
  - Winston-Salem, North Carolina, Estados Unidos, 27157-1081
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, Estados Unidos, 58103-4940
    - Dakota Cancer Institute at Innovis Health - Dakota Clinic
- Ohio
  - Akron, Ohio, Estados Unidos, 44308-1062
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, Estados Unidos, 45229-3039
    - Cincinnati Children's Hospital Medical Center
  - Cleveland, Ohio, Estados Unidos, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Estados Unidos, 44106-5065
    - Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  - Columbus, Ohio, Estados Unidos, 43205-2696
    - Columbus Children's Hospital
  - Dayton, Ohio, Estados Unidos, 45404
    - Children's Medical Center - Dayton
  - Toledo, Ohio, Estados Unidos, 43601
    - Toledo Children's Hospital
  - Toledo, Ohio, Estados Unidos, 43608
    - St. Vincent Mercy Medical Center
  - Youngstown, Ohio, Estados Unidos, 44501
    - Tod Children's Hospital - Forum Health
- Oklahoma
  - Oklahoma City, Oklahoma, Estados Unidos, 73104
    - Children's Hospital at Oklahoma University Medical Center
  - Tulsa, Oklahoma, Estados Unidos, 74136
    - CCOP - Oklahoma
  - Tulsa, Oklahoma, Estados Unidos, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Portland, Oregon, Estados Unidos, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Estados Unidos, 97227
    - Legacy Emanuel Hospital and Health Center & Children's Hospital
  - Portland, Oregon, Estados Unidos, 97239-3098
    - Doernbecher Children's Hospital at Oregon Health & Science University
- Pennsylvania
  - Danville, Pennsylvania, Estados Unidos, 17822-1320
    - Geisinger Medical Center
  - Hershey, Pennsylvania, Estados Unidos, 17033
    - Penn State Children's Hospital
  - Philadelphia, Pennsylvania, Estados Unidos, 19104
    - Children's Hospital of Philadelphia
  - Philadelphia, Pennsylvania, Estados Unidos, 19134-1095
    - St. Christopher's Hospital for Children
  - Pittsburgh, Pennsylvania, Estados Unidos, 15213
    - Children's Hospital of Pittsburgh
- Rhode Island
  - Providence, Rhode Island, Estados Unidos, 02903
    - Rhode Island Hospital
- South Carolina
  - Charleston, South Carolina, Estados Unidos, 29425-0721
    - Hollings Cancer Center at Medical University of South Carolina
  - Columbia, South Carolina, Estados Unidos, 29203
    - Palmetto Health South Carolina Cancer Center
  - Greenville, South Carolina, Estados Unidos, 29605
    - Children's Hospital of Greenville Hospital System
- South Dakota
  - Sioux Falls, South Dakota, Estados Unidos, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
  - Sioux Falls, South Dakota, Estados Unidos, 57105-1080
    - Avera Cancer Institute
- Tennessee
  - Johnson City, Tennessee, Estados Unidos, 37614-0622
    - East Tennessee State University Cancer Center at Johnson City Medical Center
  - Knoxville, Tennessee, Estados Unidos, 37901
    - East Tennessee Children's Hospital
  - Memphis, Tennessee, Estados Unidos, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Estados Unidos, 37232-6310
    - Vanderbilt Children's Hospital
- Texas
  - Amarillo, Texas, Estados Unidos, 79106
    - Texas Tech University Health Sciences Center School of Medicine
  - Austin, Texas, Estados Unidos, 78701
    - Children's Hospital of Austin
  - Dallas, Texas, Estados Unidos, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Estados Unidos, 75390-9063
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Fort Worth, Texas, Estados Unidos, 76104
    - Cook Children's Medical Center - Fort Worth
  - Galveston, Texas, Estados Unidos, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, Estados Unidos, 77030-4009
    - M.D. Anderson Cancer Center at University of Texas
  - Houston, Texas, Estados Unidos, 77030
    - Cancer Center at Baylor College of Medicine
  - Lackland Air Force Base, Texas, Estados Unidos, 78236-5300
    - Wilford Hall Medical Center
  - Lubbock, Texas, Estados Unidos, 79410
    - Covenant Children's Hospital
  - San Antonio, Texas, Estados Unidos, 78207
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Estados Unidos, 78229-3900
    - MBCCOP - South Texas Pediatrics
  - San Antonio, Texas, Estados Unidos, 78229-3902
    - Methodist Cancer Center at Methodist Specialty and Transplant Hospital
  - Temple, Texas, Estados Unidos, 76508
    - CCOP - Scott and White Hospital
  - Temple, Texas, Estados Unidos, 76508
    - Center for Cancer Prevention and Care at Scott and White Clinic
- Utah
  - Salt Lake City, Utah, Estados Unidos, 84112
    - Huntsman Cancer Institute at University of Utah
- Vermont
  - Burlington, Vermont, Estados Unidos, 05401-3498
    - Vermont Cancer Center at University of Vermont
- Virginia
  - Charlottesville, Virginia, Estados Unidos, 22908
    - University of Virginia Cancer Center
  - Falls Church, Virginia, Estados Unidos, 22042-3300
    - INOVA Fairfax Hospital
  - Norfolk, Virginia, Estados Unidos, 23507
    - Children's Hospital of The King's Daughters
  - Portsmouth, Virginia, Estados Unidos, 23708-5100
    - Naval Medical Center - Portsmouth
  - Richmond, Virginia, Estados Unidos, 23298-0121
    - Massey Cancer Center at Virginia Commonwealth University
  - Roanoke, Virginia, Estados Unidos, 24029
    - Carilion Medical Center for Children at Roanoke Community Hospital
- Washington
  - Seattle, Washington, Estados Unidos, 98105
    - Children's Hospital and Regional Medical Center - Seattle
  - Seattle, Washington, Estados Unidos, 98109-1024
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Estados Unidos, 98112
    - Group Health Central Hospital
  - Spokane, Washington, Estados Unidos, 99210-0248
    - Deaconess Medical Center
  - Tacoma, Washington, Estados Unidos, 98415-0299
    - Mary Bridge Children's Hospital and Health Center - Tacoma
  - Tacoma, Washington, Estados Unidos, 98431-0001
    - Madigan Army Medical Center
- West Virginia
  - Charleston, West Virginia, Estados Unidos, 25302
    - West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
  - Huntington, West Virginia, Estados Unidos, 25701
    - Cabell Huntington Hospital
  - Morgantown, West Virginia, Estados Unidos, 26506-9300
    - Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Wisconsin
  - Green Bay, Wisconsin, Estados Unidos, 54301
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Green Bay, Wisconsin, Estados Unidos, 54301
    - Bellin Memorial Hospital
  - Green Bay, Wisconsin, Estados Unidos, 54307-9070
    - St. Vincent Hospital
  - La Crosse, Wisconsin, Estados Unidos, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Madison, Wisconsin, Estados Unidos, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, Estados Unidos, 54449
    - CCOP - Marshfield Clinic Research Foundation
  - Marshfield, Wisconsin, Estados Unidos, 54449-5772
    - Marshfield Clinic - Marshfield Center
  - Milwaukee, Wisconsin, Estados Unidos, 53226
    - Midwest Children's Cancer Center
Nueva Zelanda
- - Auckland, Nueva Zelanda
    - Starship Children's Health
Países Bajos
- - Groningen, Países Bajos, 9700 RB
    - University Medical Center Groningen
Puerto Rico
- - San Juan, Puerto Rico, 00936-5067
    - Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
  - Santurce, Puerto Rico, 00912
    - San Jorge Children's Hospital
Suiza
- - Bern, Suiza, CH 3010
    - Swiss Pediatric Oncology Group Bern
  - Geneva, Suiza, CH 1211
    - Swiss Pediatric Oncology Group Geneva
  - Lausanne, Suiza, CH 1011
    - Swiss Pediatric Oncology Group Lausanne

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 20 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: N / A
Modelo Intervencionista: Asignación de un solo grupo
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: Tratamiento Ver descripción detallada.	Droga: carboplatino Otros nombres: Paraplatino NSC-241240 Droga: ciclofosfamida Otros nombres: Citoxano NSC-26271 Droga: etopósido Otros nombres: VP-16 VePesid NSC-141540 Procedimiento: terapia neoadyuvante Droga: clorhidrato de doxorrubicina Otros nombres: Adriamicina NSC-123127 Procedimiento: cirugía convencional Biológico: filgrastim Otros nombres: G-CSF Factor estimulante de colonias de granulocitos r-metHuG-CSF NSC n.º 614629 Neupogen® Biológico: sargramostim Otros nombres: Leucina Proquina GM-CSF Factor estimulante de colonias de macrófagos y granulocitos rhu GM-CSF NSC n.º 613795

Grupo de participantes/brazo

Intervención / Tratamiento

Experimental: Tratamiento

Ver descripción detallada.

Droga: carboplatino

Otros nombres:

Paraplatino
NSC-241240

Droga: ciclofosfamida

Otros nombres:

Citoxano
NSC-26271

Droga: etopósido

Otros nombres:

VP-16
VePesid
NSC-141540

Procedimiento: terapia neoadyuvante

Droga: clorhidrato de doxorrubicina

Otros nombres:

Adriamicina
NSC-123127

Procedimiento: cirugía convencional

Biológico: filgrastim

Otros nombres:

G-CSF
Factor estimulante de colonias de granulocitos
r-metHuG-CSF
NSC n.º 614629
Neupogen®

Biológico: sargramostim

Otros nombres:

Leucina
Proquina
GM-CSF
Factor estimulante de colonias de macrófagos y granulocitos
rhu GM-CSF
NSC n.º 613795

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Supervivencia libre de eventos

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Children's Oncology Group

Colaboradores

National Cancer Institute (NCI)

Investigadores

Silla de estudio: David L. Baker, MD, MBBS, FRACP, FRCPA, Princess Margaret Hospital for Children

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 1988

Finalización primaria (Actual)

1 de septiembre de 2006

Finalización del estudio (Actual)

1 de enero de 2011

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 1999

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2003

Publicado por primera vez (Estimar)

27 de enero de 2003

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de agosto de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2014

Última verificación

1 de julio de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

A3961
COG-A3961 (Otro identificador: Children's Oncology Group)
CCG-A3961 (Otro identificador: Children's Cancer Group)
POG-A3961 (Otro identificador: Pediatric Oncology Group)
CDR0000065804 (Otro identificador: Clinical Trials.gov)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Combination Chemotherapy in Treating Children With Neuroblastoma

Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Descripción detallada

Tipo de estudio

Inscripción (Actual)

Fase

Contactos y Ubicaciones

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Colaboradores e Investigadores

Patrocinador

Colaboradores

Investigadores

Publicaciones y enlaces útiles

Publicaciones Generales

Fechas de registro del estudio

Fechas importantes del estudio

Inicio del estudio

Finalización primaria (Actual)

Finalización del estudio (Actual)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Estimar)

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio