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NCT00253721 · ClinicalTrials.gov registry record · Phase 1

Melphalan With BBBD in Treating Patients With Brain Malignancies

A Phase 1 study, sponsored by OHSU Knight Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
21
Enrollment target

NCT00253721: Clinical Trial Phase 1 study, sponsored by OHSU Knight Cancer Institute.

NCT00253721 is a Phase 1 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00253721, a Phase 1 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may open the blood vessels around the brain \[Blood-Brain Barrier Disruption (BBBD)\]and allow melphalan to be carried directly to the brain tumor. Giving melphalan together with BBBD may be an effective treatment for central nervous system cancer. PURPOSE: This phase I trial is studying side effects and best dose of melphalan when given together with mannitol in treating patients with central nervous system cancer.

Primary Outcome

MTD = dose of Melphalan that produces grade 3 neurotoxicity in 33% of subjects

Interventions

  • DRUG Melphalan

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 1998-05
Est. Completion 2016-12
Phase Phase 1
OHSU Knight Cancer Institute

211 total trials

Why NCT00253721 stopped before completion

NCT00253721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

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

NCT00253721 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00253721 about?

NCT00253721 is a clinical study titled "Melphalan With BBBD in Treating Patients With Brain Malignancies". RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may open the blood vessels a...

What is the current status of trial NCT00253721?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 1998-05. Estimated completion is 2016-12.

What interventions are being tested in trial NCT00253721?

The interventions under investigation include: Melphalan (DRUG).

Who is sponsoring clinical trial NCT00253721?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00253721's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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 NCT00253721, the US trial registry maintained by the National Library of Medicine. NCT00253721 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.