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NCT00093353 · ClinicalTrials.gov registry record · Phase 1

N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00093353: Completed Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

NCT00093353 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00093353, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.

Interventions

  • DRUG temozolomide
  • DRUG irinotecan hydrochloride
  • DRUG cefixime

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-05
Phase Phase 1

What the finished NCT00093353 record still lists

NCT00093353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 3 interventions - of which temozolomide is the first listed.

NCT00093353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00093353 about?

NCT00093353 is a clinical study titled "N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma". RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing ...

What is the current status of trial NCT00093353?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-05.

What interventions are being tested in trial NCT00093353?

The interventions under investigation include: temozolomide (DRUG), irinotecan hydrochloride (DRUG), cefixime (DRUG).

Who is sponsoring clinical trial NCT00093353?

This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00093353's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT00093353, the US trial registry maintained by the National Library of Medicine. NCT00093353 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.