Neuroblastoma Clinical Trial
Official title:
Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study
| Verified date | July 2014 |
| Source | Children's Oncology Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 573 |
| Est. completion date | January 2011 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 20 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Children's Hospital | Brisbane | Queensland |
| Australia | Women's and Children's Hospital | North Adelaide | South Australia |
| Australia | Royal Children's Hospital | Parkville | Victoria |
| Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
| Australia | Sydney Children's Hospital | Randwick | New South Wales |
| Australia | Children's Hospital at Westmead | Westmead | New South Wales |
| Canada | Alberta Children's Hospital | Calgary | Alberta |
| Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
| Canada | IWK Health Centre | Halifax | Nova Scotia |
| Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
| Canada | Children's Hospital of Western Ontario | London | Ontario |
| Canada | Hopital Sainte Justine | Montreal | Quebec |
| Canada | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec |
| Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
| Canada | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan |
| Canada | Centre de Recherche du Centre Hospitalier de l'Universite Laval | Sainte Foy | Quebec |
| Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
| Canada | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador |
| Canada | Hospital for Sick Children | Toronto | Ontario |
| Canada | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia |
| Canada | CancerCare Manitoba | Winnipeg | Manitoba |
| Netherlands | University Medical Center Groningen | Groningen | |
| New Zealand | Starship Children's Health | Auckland | |
| Puerto Rico | Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus | San Juan | |
| Puerto Rico | San Jorge Children's Hospital | Santurce | |
| Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
| Switzerland | Swiss Pediatric Oncology Group Geneva | Geneva | |
| Switzerland | Swiss Pediatric Oncology Group Lausanne | Lausanne | |
| United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
| United States | Children's Hospital at Albany Medical Center | Albany | New York |
| United States | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
| United States | Texas Tech University Health Sciences Center School of Medicine | Amarillo | Texas |
| United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
| United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
| United States | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta | Georgia |
| United States | MBCCOP-Medical College of Georgia Cancer Center | Augusta | Georgia |
| United States | Children's Hospital of Austin | Austin | Texas |
| United States | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland |
| United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
| United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
| United States | Pediatric Specialty Clinic at Eastern Maine Medical Center | Bangor | Maine |
| United States | Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama |
| United States | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho |
| United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Floating Hospital for Children | Boston | Massachusetts |
| United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
| United States | Brookdale University Hospital and Medical Center | Brooklyn | New York |
| United States | Brooklyn Hospital Center | Brooklyn | New York |
| United States | Maimonides Medical Center | Brooklyn | New York |
| United States | SUNY Downstate Medical Center | Brooklyn | New York |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Vermont Cancer Center at University of Vermont | Burlington | Vermont |
| United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
| United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
| United States | West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia |
| United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
| United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
| United States | University of Virginia Cancer Center | Charlottesville | Virginia |
| United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Chicago Cancer Research Center | Chicago | Illinois |
| United States | University of Illinois at Chicago Cancer Center | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
| United States | Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland | Ohio |
| United States | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina |
| United States | University of Missouri - Columbia | Columbia | Missouri |
| United States | Columbus Children's Hospital | Columbus | Ohio |
| United States | Medical City Dallas Hospital | Dallas | Texas |
| United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| United States | Children's Medical Center - Dayton | Dayton | Ohio |
| United States | Children's Hospital Cancer Center | Denver | Colorado |
| United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
| United States | Blank Children's Hospital | Des Moines | Iowa |
| United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
| United States | Children's Hospital of Michigan | Detroit | Michigan |
| United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Detroit | Michigan |
| United States | Southern California Permanente Medical Group | Downey | California |
| United States | City of Hope Comprehensive Cancer Center | Duarte | California |
| United States | St. Mary's - Duluth Clinic Cancer Center | Duluth | Minnesota |
| United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
| United States | INOVA Fairfax Hospital | Falls Church | Virginia |
| United States | Dakota Cancer Institute at Innovis Health - Dakota Clinic | Fargo | North Dakota |
| United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
| United States | Hurley Medical Center | Flint | Michigan |
| United States | Broward General Medical Center Cancer Center | Fort Lauderdale | Florida |
| United States | Children's Hospital of Southwest Florida | Fort Myers | Florida |
| United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
| United States | University of Florida Shands Cancer Center | Gainesville | Florida |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | DeVos Children's Hospital | Grand Rapids | Michigan |
| United States | Bellin Memorial Hospital | Green Bay | Wisconsin |
| United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
| United States | St. Vincent Hospital | Green Bay | Wisconsin |
| United States | Children's Hospital of Greenville Hospital System | Greenville | South Carolina |
| United States | Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital | Greenville | North Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Penn State Children's Hospital | Hershey | Pennsylvania |
| United States | Joe DiMaggio Children's Hospital at Memorial | Hollywood | Florida |
| United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
| United States | MBCCOP - Hawaii | Honolulu | Hawaii |
| United States | Tripler Army Medical Center | Honolulu | Hawaii |
| United States | Cancer Center at Baylor College of Medicine | Houston | Texas |
| United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
| United States | Cabell Huntington Hospital | Huntington | West Virginia |
| United States | Riley's Children Cancer Center at Riley Hospital for Children | Indianapolis | Indiana |
| United States | St. Vincent Indianapolis Hospital | Indianapolis | Indiana |
| United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Nemours Children's Clinic | Jacksonville | Florida |
| United States | East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City | Tennessee |
| United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | East Tennessee Children's Hospital | Knoxville | Tennessee |
| United States | Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
| United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
| United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
| United States | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan |
| United States | Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky |
| United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
| United States | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
| United States | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Kosair Children's Hospital | Louisville | Kentucky |
| United States | Covenant Children's Hospital | Lubbock | Texas |
| United States | Medical Center of Central Georgia | Macon | Georgia |
| United States | Children's Hospital Central California | Madera | California |
| United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
| United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
| United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
| United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
| United States | Baptist-South Miami Regional Cancer Program | Miami | Florida |
| United States | Jackson Memorial Hospital | Miami | Florida |
| United States | Miami Children's Hospital | Miami | Florida |
| United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
| United States | Children's Hospitals and Clinics - Minneapolis/St. Paul | Minneapolis | Minnesota |
| United States | University of South Alabama Cancer Research Institute | Mobile | Alabama |
| United States | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia |
| United States | Vanderbilt Children's Hospital | Nashville | Tennessee |
| United States | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | Yale Comprehensive Cancer Center at Yale University School of Medicine | New Haven | Connecticut |
| United States | Schneider Children's Hospital | New Hyde Park | New York |
| United States | Children's Hospital of New Orleans | New Orleans | Louisiana |
| United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
| United States | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana |
| United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Mount Sinai Medical Center | New York | New York |
| United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
| United States | Newark Beth Israel Medical Center | Newark | New Jersey |
| United States | Children's Hospital of the King's Daughters | Norfolk | Virginia |
| United States | Advocate Hope Children's Hospital | Oak Lawn | Illinois |
| United States | Children's Hospital and Research Center - Oakland | Oakland | California |
| United States | Children's Hospital at Oklahoma University Medical Center | Oklahoma City | Oklahoma |
| United States | Children's Hospital of Omaha | Omaha | Nebraska |
| United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California |
| United States | Children's Hospital of Orange County | Orange | California |
| United States | Florida Hospital Cancer Institute | Orlando | Florida |
| United States | Nemours Children's Clinic - Orlando | Orlando | Florida |
| United States | Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California |
| United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
| United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
| United States | Sacred Heart Children's Hospital | Pensacola | Florida |
| United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
| United States | Doernbecher Children's Hospital at Oregon Health & Science University | Portland | Oregon |
| United States | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon |
| United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia |
| United States | Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia |
| United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
| United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
| United States | CCOP - Beaumont | Royal Oak | Michigan |
| United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
| United States | Kaiser Permanente Medical Center - Sacramento | Sacramento | California |
| United States | Sutter Cancer Center | Sacramento | California |
| United States | University of California Davis Cancer Center | Sacramento | California |
| United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
| United States | St. Louis Children's Hospital | Saint Louis | Missouri |
| United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
| United States | MBCCOP - South Texas Pediatrics | San Antonio | Texas |
| United States | Methodist Cancer Center at Methodist Specialty and Transplant Hospital | San Antonio | Texas |
| United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
| United States | Children's Hospital and Health Center - San Diego | San Diego | California |
| United States | Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego | San Diego | California |
| United States | UCSF Comprehensive Cancer Center | San Francisco | California |
| United States | Santa Barbara Cottage Children's Hospital | Santa Barbara | California |
| United States | Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California |
| United States | Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
| United States | Maine Children's Cancer Program | Scarborough | Maine |
| United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
| United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
| United States | Group Health Central Hospital | Seattle | Washington |
| United States | Walter Reed Army Medical Center | Silver Spring | Maryland |
| United States | Avera Cancer Institute | Sioux Falls | South Dakota |
| United States | Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota |
| United States | Deaconess Medical Center | Spokane | Washington |
| United States | Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | All Children's Hospital | St. Petersburg | Florida |
| United States | Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York |
| United States | Valerie Fund Children's Center at Atlantic Health | Summit | New Jersey |
| United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
| United States | Madigan Army Medical Center | Tacoma | Washington |
| United States | Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington |
| United States | St. Joseph's Children's Hospital of Tampa | Tampa | Florida |
| United States | CCOP - Scott and White Hospital | Temple | Texas |
| United States | Center for Cancer Prevention and Care at Scott and White Clinic | Temple | Texas |
| United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
| United States | Toledo Children's Hospital | Toledo | Ohio |
| United States | General Robert Huyser Cancer Center at David Grant Medical Center | Travis Air Force Base | California |
| United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
| United States | CCOP - Oklahoma | Tulsa | Oklahoma |
| United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
| United States | New York Medical College | Valhalla | New York |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Lombardi Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
| United States | Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida |
| United States | Wesley Medical Center | Wichita | Kansas |
| United States | Alfred I. duPont Hospital for Children | Wilmington | Delaware |
| United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
| United States | UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts |
| United States | Tod Children's Hospital - Forum Health | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland,
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 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.
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 ne — View Citation
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. — View Citation
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. — View Citation
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.
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