N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Public ClinicalTrials.gov record NCT00253435. 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
I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.
Study identification
- NCT ID
- NCT00253435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- Filgrastim Biological
- Carboplatin Drug
- Etoposide Drug
- Melphalan Drug
- Peripheral blood stem cell infusion Procedure
- 131I-MIBG Radiation
- Radiation therapy Radiation
Biological · Drug · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 1 Year to 29 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
- Sep 2005 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Apr 28, 2026
2005 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027-0700 | — |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Palo Alto | California | 94304 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | — |
| University of Chicago Comer Children's Hospital | Chicago | Illinois | 60637 | — |
| 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 | — |
| Morgan Stanley Children's Hospital of New York-Presbyterian | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | — |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas | 77030-2399 | — |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | — |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00253435, 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 Apr 28, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00253435 live on ClinicalTrials.gov.