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NCT00038389 · ClinicalTrials.gov registry record · Phase 1

Study of Vioxx and Radiation Therapy for Brainstem Glioma

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
8
Enrollment target

NCT00038389: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00038389 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00038389, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.

Interventions

  • DRUG Vioxx

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2001-10
Est. Completion 2005-01
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00038389

The ClinicalTrials.gov registry entry for NCT00038389 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Vioxx is the first listed.

NCT00038389 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00038389 about?

NCT00038389 is a clinical study titled "Study of Vioxx and Radiation Therapy for Brainstem Glioma". It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors...

What is the current status of trial NCT00038389?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2001-10. Estimated completion is 2005-01.

What interventions are being tested in trial NCT00038389?

The interventions under investigation include: Vioxx (DRUG).

Who is sponsoring clinical trial NCT00038389?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 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, the data changelog, or report a data error.