Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Public ClinicalTrials.gov record NCT01175356. 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 COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.
Study identification
- NCT ID
- NCT01175356
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 99 participants
Conditions and interventions
Conditions
Interventions
- 3-Dimensional Conformal Radiation Therapy Radiation
- Autologous Hematopoietic Stem Cell Transplantation Procedure
- Busulfan Drug
- Cisplatin Drug
- Cyclophosphamide Drug
- Doxorubicin Hydrochloride Drug
- Etoposide Phosphate Drug
- External Beam Radiation Therapy Radiation
- In Vitro-Treated Peripheral Blood Stem Cell Transplantation Procedure
- Intensity-Modulated Radiation Therapy Radiation
- Iobenguane I-131 Radiation
- Isotretinoin Drug
- Laboratory Biomarker Analysis Other
- Melphalan Drug
- Pharmacological Study Other
- Questionnaire Administration Other
- Therapeutic Conventional Surgery Procedure
- Topotecan Hydrochloride Drug
- Vincristine Sulfate Drug
Radiation · Procedure · Drug + 1 more
Eligibility (public fields only)
- Age range
- 1 Year to 30 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
- Dec 20, 2011
- Primary completion
- Sep 27, 2016
- Completion
- Dec 30, 2025
- Last update posted
- Jan 22, 2026
2011 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 23
| 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 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01175356, 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 Jan 22, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01175356 live on ClinicalTrials.gov.