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NCT00670410 · ClinicalTrials.gov registry record · Phase 1

Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma

A Phase 1 study, sponsored by Columbia University.

Terminated
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00670410: Clinical Trial Phase 1 study, sponsored by Columbia University.

NCT00670410 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00670410, a Phase 1 study, was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most common malignant tumor of childhood. Although modest advances have been made over the past 20 years children with high-risk neuroblastoma continue to have an unsatisfactory long-term survival. This study will administer induction chemotherapy followed by high-dose (myeloablative) chemotherapy with autologous stem cell transplantation, followed by radiation therapy, then immunotherapy with a non myeloablative allogeneic stem cell transplant for treatment of neuroblastoma. The purpose of this clinical research trial is to study the feasibility of giving immunotherapy with a non-myeloablative allogeneic transplant (NAT/AlloSCT), following myeloablative therapy and autologous stem cell transplant (MAT/AutoSCT). This study will also determine the side effects as well as the response rate for each group of patients (treatment arm).

Primary Outcome

The distribution of the time to neutrophil and platelet engraftment following consolidation (myeloablative) and intensification (non-ablation) will be estimated using the product-limit method of the Kaplan and Meier.

Interventions

  • DRUG Fludarabine
  • DRUG Busulfan
  • DRUG Thymoglobulin
  • PROCEDURE Related donor transplant
  • PROCEDURE Cord blood transplant

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2003-11
Est. Completion 2010-12
Phase Phase 1
Columbia University

958 total trials

Why NCT00670410 stopped before completion

NCT00670410 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.

NCT00670410 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00670410 about?

NCT00670410 is a clinical study titled "Autologous Transplant Followed by Allogeneic Transplant for High Risk Neuroblastoma". Neuroblastoma is a malignant tumor of the sympathetic nervous system. It is the second most common malignant tumor of childhood. Although modest advances have been made over the past 20 years children with high-risk neuroblastoma continue to have an unsatisfactory long-term survival. This study will...

What is the current status of trial NCT00670410?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2003-11. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00670410?

The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Thymoglobulin (DRUG), Related donor transplant (PROCEDURE), Cord blood transplant (PROCEDURE).

Who is sponsoring clinical trial NCT00670410?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00670410's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 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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Source: ClinicalTrials.gov NCT00670410, the US trial registry maintained by the National Library of Medicine. NCT00670410 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.