ClinicalTrials.gov record
Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
ClinicalTrials.gov ID: NCT01767194
Public ClinicalTrials.gov record NCT01767194. 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
A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (Ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.
Study identification
- NCT ID
- NCT01767194
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 73 participants
Conditions and interventions
Conditions
Interventions
- Dinutuximab Biological
- Irinotecan Hydrochloride Drug
- Laboratory Biomarker Analysis Other
- Sargramostim Biological
- Temozolomide Drug
- Temsirolimus Drug
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Feb 12, 2013 (Actual)
- Primary completion
- Jun 30, 2018 (Actual)
- Completion
- Sep 30, 2022 (Actual)
- Last update posted
- Oct 24, 2022
2013 – 2022
United States locations
- U.S. sites
- 136
- U.S. states
- 45
- U.S. cities
- 109
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Lee Memorial Health System | Fort Myers | Florida | 33901 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Saint Mary's Hospital | West Palm Beach | Florida | 33407 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | — |
| Michigan State University Clinical Center | East Lansing | Michigan | 48824-7016 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89169 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| NYU Winthrop Hospital | Mineola | New York | 11501 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| The Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| 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 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01767194, 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 Oct 24, 2022 · Synced Oct 25, 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 NCT01767194 live on ClinicalTrials.gov.