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NCT00437957 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00437957 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 10 participants.

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The verdict

NCT00437957, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest dose of valproic acid that can be given together with temozolomide and whole brain radiation. We will also study the drug combination's effectiveness in treating cancer. While both of these drugs and whole brain radiation have been used in people for many years, they have never been combined for the purpose of treating patients with cancer.

Interventions

  • DRUG Temozolomide
  • DRUG Valproic Acid
  • PROCEDURE Whole Brain Radiation Therapy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2006-12
Est. Completion 2009-04
Phase Phase 1

What the Registry Record Tells You About NCT00437957

The ClinicalTrials.gov registry entry for NCT00437957 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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

NCT00437957 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00437957 about?

NCT00437957 is a clinical study titled "Phase I Study of Temozolomide, Valproic Acid and Radiation Therapy in Patients With Brain Metastases". This type of study is called a "Phase I study". Its purpose is to determine the side effects of the two medicines listed in this study when given together with whole brain radiation, and the highest dose of valproic acid that can be given together with temozolomide and whole brain radiation. We will...

What is the current status of trial NCT00437957?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2006-12. Estimated completion is 2009-04.

What interventions are being tested in trial NCT00437957?

The interventions under investigation include: Temozolomide (DRUG), Valproic Acid (DRUG), Whole Brain Radiation Therapy (PROCEDURE).

Who is sponsoring clinical trial NCT00437957?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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

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.