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NCT00083135 · ClinicalTrials.gov registry record · Phase 1
N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00083135: Completed Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT00083135 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00083135, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.
Interventions
- PROCEDURE peripheral blood stem cell transplantation
- BIOLOGICAL filgrastim
- PROCEDURE autologous bone marrow transplantation
- RADIATION iobenguane I 131
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-03 |
| Phase | Phase 1 |
What the finished NCT00083135 record still lists
NCT00083135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 4 interventions - of which peripheral blood stem cell transplantation is the first listed.
NCT00083135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00083135 about?
NCT00083135 is a clinical study titled "N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation". RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I tri...
What is the current status of trial NCT00083135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2004-03.
What interventions are being tested in trial NCT00083135?
The interventions under investigation include: peripheral blood stem cell transplantation (PROCEDURE), filgrastim (BIOLOGICAL), autologous bone marrow transplantation (PROCEDURE), iobenguane I 131 (RADIATION).
Who is sponsoring clinical trial NCT00083135?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00083135's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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