ClinicalTrials.gov record
Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
ClinicalTrials.gov ID: NCT00499616
Public ClinicalTrials.gov record NCT00499616. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases. PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.
Study identification
- NCT ID
- NCT00499616
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 464 participants
Conditions and interventions
Conditions
Interventions
- carboplatin Drug
- cyclophosphamide Drug
- doxorubicin hydrochloride Drug
- etoposide Drug
- topotecan hydrochloride Drug
- Isotretinoin Drug
- Surgery Procedure
- Filgrastim Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- Up to 12 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 8, 2007 (Actual)
- Primary completion
- Jun 30, 2014 (Actual)
- Completion
- Jun 30, 2021 (Actual)
- Last update posted
- Jul 6, 2021
2007 – 2021
United States locations
- U.S. sites
- 166
- U.S. states
- 46
- U.S. cities
- 140
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016-7710 | — |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724-5024 | — |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Southern California Permanente Medical Group | Downey | California | 90027 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | — |
| 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 | — |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Central California | Madera | California | 93638-8762 | — |
| Children's Hospital and Research Center Oakland | Oakland | California | 94609 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | 95798 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| University of California Davis Cancer Center | Sacramento | California | 95817 | — |
| Kaiser Permanente Medical Center - Oakland | Sacramento | California | 95825 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123-4282 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | 80045 | — |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520-8028 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Lombardi Comprehensive 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 | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | — |
| Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | 33316 | — |
| Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida | 33901 | — |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | — |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | — |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | — |
| Baptist-South Miami Regional Cancer Program | Miami | Florida | 33176 | — |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | — |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | — |
| Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach | Florida | 33407 | — |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | — |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912-3730 | — |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | — |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | — |
| Tripler Army Medical Center | Tripler AMC | Hawaii | 96859-5000 | — |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712-6297 | — |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | — |
| Children's Memorial Hospital - Chicago | Chicago | Illinois | 60614 | — |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | — |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Oak Lawn | Illinois | 60453 | — |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | — |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | — |
| Simmons Cooper Cancer Institute | Springfield | Illinois | 62794-9677 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | — |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | — |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | — |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | Scarborough | Maine | 04074-9308 | — |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore | Maryland | 21215 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | — |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | — |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-5381 | — |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216-4505 | — |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | — |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | — |
| Children's Hospital | Omaha | Nebraska | 68114-4113 | — |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | — |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89109-2306 | — |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | — |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | — |
| Overlook Hospital | Morristown | New Jersey | 07962 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| St. Joseph's Hospital and Medical Center | Paterson | New Jersey | 07503 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | — |
| Albany Medical Center Hospital | Albany | New York | 12208-3419 | — |
| Maimonides Cancer Center at Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Schneider Children's Hospital | New Hyde Park | New York | 11040 | — |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | — |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | — |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | — |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Mission Hospitals - Memorial Campus | Asheville | North Carolina | 28801 | — |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | — |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | — |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina | 28233-3549 | — |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | — |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | — |
| Dayton Children's - Dayton | Dayton | Ohio | 45404-1815 | — |
| Toledo Hospital | Toledo | Ohio | 43606 | — |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | — |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | — |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | — |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | — |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033-0850 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-9786 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island | 02903 | — |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Palmetto Health South Carolina Cancer Center | Columbia | South Carolina | 29203 | — |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | — |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | — |
| T.C. Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | — |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37901 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | — |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | 79106 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | — |
| Baylor University Medical Center - Houston | Houston | Texas | 77030-2399 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | — |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | — |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | — |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042-3300 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | — |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | — |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | — |
| Carilion Medical Center for Children at Roanoke Community Hospital | Roanoke | Virginia | 24014 | — |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | — |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington | 99220-2555 | — |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | 98405 | — |
| Madigan Army Medical Center - Tacoma | Tacoma | Washington | 98431 | — |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25302 | — |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | — |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | — |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | — |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00499616, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 6, 2021 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00499616 live on ClinicalTrials.gov.