ClinicalTrials.gov record
Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
ClinicalTrials.gov ID: NCT01055314
Public ClinicalTrials.gov record NCT01055314. 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 Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells.
Study identification
- NCT ID
- NCT01055314
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Interventions
- Cixutumumab Biological
- Cyclophosphamide Drug
- Dactinomycin Biological
- Doxorubicin Hydrochloride Drug
- Etoposide Drug
- Ifosfamide Drug
- Irinotecan Hydrochloride Drug
- Laboratory Biomarker Analysis Other
- Temozolomide Drug
- Vincristine Sulfate Liposome Drug
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- Up to 49 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
- Jan 2010 (Type not available)
- Primary completion
- Jun 2016 (Actual)
- Completion
- Jun 2016 (Actual)
- Last update posted
- Aug 29, 2017
2010 – 2016
United States locations
- U.S. sites
- 121
- U.S. states
- 43
- U.S. cities
- 103
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Southern California Permanente Medical Group | Downey | California | 90242 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | — |
| Mattel Children's Hospital UCLA | Los Angeles | California | 90095 | — |
| Children's Hospital Central California | Madera | California | 93636-8762 | — |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609-1809 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Childrens Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| 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 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| 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 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61602 | — |
| Southern Illinois University | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| The Childrens Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Saint John's Mercy Medical Center | St Louis | Missouri | 63141 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | — |
| UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Overlook Hospital | Summit | New Jersey | 07902 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| 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 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | — |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| 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 | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | — |
| Childrens Hospital-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 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| West Virginia University Charleston | Charleston | West Virginia | 25304 | — |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | — |
| Midwest Children's Cancer Center | 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 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01055314, 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 Aug 29, 2017 · Synced Oct 21, 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 NCT01055314 live on ClinicalTrials.gov.