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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 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 18 participants.

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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

FieldValue
Enrollment Target 18 participants
Start Date 2004-03
Phase Phase 1

What the Registry Record Tells You About NCT00083135

The ClinicalTrials.gov registry entry for NCT00083135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which peripheral blood stem cell transplantation is the first listed.

NCT00083135 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.