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NCT00516282 · ClinicalTrials.gov registry record · Phase 1

VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma

A Phase 1 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 1
Development phase
14
Enrollment target

NCT00516282: Clinical Trial Phase 1 study, sponsored by Northwestern University.

NCT00516282 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00516282, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M when given together with temozolomide and to see how well it works in treating patients with progressive or relapsed malignant glioma.

Primary Outcome

To determine the MTD of CLORETAZINE when administered with Temodar® in patients with malignant gliomas in first or second relapse

Interventions

  • DRUG temozolomide
  • DRUG CLORETAZINE

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-08
Est. Completion 2009-10
Phase Phase 1
Northwestern University

1,209 total trials

Why NCT00516282 stopped before completion

NCT00516282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which temozolomide is the first listed.

NCT00516282 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00516282 about?

NCT00516282 is a clinical study titled "VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma". RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This...

What is the current status of trial NCT00516282?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-08. Estimated completion is 2009-10.

What interventions are being tested in trial NCT00516282?

The interventions under investigation include: temozolomide (DRUG), CLORETAZINE (DRUG).

Who is sponsoring clinical trial NCT00516282?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00516282's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 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 NCT00516282, the US trial registry maintained by the National Library of Medicine. NCT00516282 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.