AzTrials
AzTrials

NeuroblastomaPhase 3NCT00003093

Combination Chemotherapy in Treating Children With Neuroblastoma

A Phase 3 study testing filgrastim, sargramostim and carboplatin in people with Neuroblastoma, run by Children's Oncology Group at 235 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 20 years
Conditions the study is for
Neuroblastoma
What is being tested?
filgrastim, sargramostim and carboplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
573 participants
Where
235 sitesin 7 countries
Study dates
Mar 1988to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

235 sites in 7 countries.

235 sites in 7 countries

United States207 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062

  • Children's Hospital at Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0914

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

    Atlanta, Georgia, 30342

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-4000

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-7223

  • Pediatric Specialty Clinic at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

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

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201-5493

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

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

    Chapel Hill, North Carolina, 27599

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60601

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago Cancer Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Columbus Children's Hospital

    Columbus, Ohio, 43205-2696

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9063

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404

  • Children's Hospital Cancer Center

    Denver, Colorado, 80218

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Blank Children's Hospital

    Des Moines, Iowa, 50308

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

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

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Dakota Cancer Institute at Innovis Health - Dakota Clinic

    Fargo, North Dakota, 58103-4940

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cancer Center at Baylor College of Medicine

    Houston, Texas, 77030

  • Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Riley's Children Cancer Center at Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37614-0622

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007-5364

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236-5300

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0284

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801-1428

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-3830

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449-5772

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics - Minneapolis/St. Paul

    Minneapolis, Minnesota, 55404

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36604

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232-6310

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8064

  • Schneider Children's Hospital

    New Hyde Park, New York, 11040

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital and Research Center - Oakland

    Oakland, California, 94609-1809

  • Children's Hospital at Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 94304

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Doernbecher Children's Hospital at Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0121

  • Carilion Medical Center for Children at Roanoke Community Hospital

    Roanoke, Virginia, 24029

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • MBCCOP - South Texas Pediatrics

    San Antonio, Texas, 78229-3900

  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital

    San Antonio, Texas, 78229-3902

  • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143

  • Santa Barbara Cottage Children's Hospital

    Santa Barbara, California, 93102

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31405

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Walter Reed Army Medical Center

    Silver Spring, Maryland, 20910

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-1080

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9658

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01107

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11794-8174

  • Valerie Fund Children's Center at Atlantic Health

    Summit, New Jersey, 07901

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Mary Bridge Children's Hospital and Health Center - Tacoma

    Tacoma, Washington, 98415-0299

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-0001

  • St. Joseph's Children's Hospital of Tampa

    Tampa, Florida, 33677-4227

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Toledo Children's Hospital

    Toledo, Ohio, 43601

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • General Robert Huyser Cancer Center at David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19899

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01655

  • Tod Children's Hospital - Forum Health

    Youngstown, Ohio, 44501

Other trials in United States

Canada15 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, NS B3J 3G9

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8S 4J9

  • Children's Hospital of Western Ontario

    London, Ontario, N6C 2V5

  • Montreal Children's Hospital at McGill University Health Center

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, CH 1011

Other trials in Switzerland

Puerto Rico2 sites

  • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

    San Juan, 00936-5067

  • San Jorge Children's Hospital

    Santurce, 00912

Other trials in Puerto Rico

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

New Zealand1 site

  • Starship Children's Health

    Auckland

Other trials in New Zealand

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Neuroblastoma
Keywords
regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, localized unresectable neuroblastoma
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003093
Study groupRoleWhat they receive
TreatmentExperimentalSee detailed description.
Receives: Biological: filgrastim; Biological: sargramostim; Drug: carboplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Procedure: conventional surgery; Procedure: neoadjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1988
  3. Primary completionSep 2006
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
573 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003093
Sponsor's protocol ID
A3961
Other IDs
COG-A3961, CCG-A3961, POG-A3961, CDR0000065804
Status last verified
Jul 2014
First submitted
1 Nov 1999
Last updated
1 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23050139

  • 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.

    PubMed 22493777

  • 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.

    PubMed 20879880

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, sargramostim and carboplatin in people with Neuroblastoma, run by Children's Oncology Group at 235 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003093, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.

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