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NCT00659984 · ClinicalTrials.gov registry record · Phase 2

N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

A Phase 2 study, sponsored by Molecular Insight Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
15
Enrollment target

NCT00659984: Completed Phase 2 study, sponsored by Molecular Insight Pharmaceuticals.

NCT00659984 is a Phase 2 study that has completed, run by Molecular Insight Pharmaceuticals. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00659984, a Phase 2 study, has completed, sponsored by Molecular Insight Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by I 131 MIBG. PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.

Primary Outcome

The maximum tolerated dose (MTD) was defined as the dose immediately below the level at which dose escalation would be stopped due to dose limiting toxicities (DLTs). Once the MTD was reached, an additional 3 patients were to be treated at that dose level, for a total of 6 patients at that planned dose level. DLTs were defined as any of the events that are possibly, probably or definitely attributable to UltratraceTM iobenguane I 131. The MTD was supposed to be the highest dose tested at which f

Interventions

  • DRUG UltratraceTM Iobenguane I 131 Imaging
  • DRUG UltratraceTM Iobenguane I 131 Therapy

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2008-06
Est. Completion 2010-11
Phase Phase 2
Molecular Insight Pharmaceuticals

13 total trials

What the finished NCT00659984 record still lists

NCT00659984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which UltratraceTM Iobenguane I 131 Imaging is the first listed.

NCT00659984 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00659984 about?

NCT00659984 is a clinical study titled "N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma". RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed ...

What is the current status of trial NCT00659984?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2008-06. Estimated completion is 2010-11.

What interventions are being tested in trial NCT00659984?

The interventions under investigation include: UltratraceTM Iobenguane I 131 Imaging (DRUG), UltratraceTM Iobenguane I 131 Therapy (DRUG).

Who is sponsoring clinical trial NCT00659984?

This trial is sponsored by Molecular Insight Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00659984's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00659984, the US trial registry maintained by the National Library of Medicine. NCT00659984 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.