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NCT00308165 · ClinicalTrials.gov registry record · Phase 1

Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors

A Phase 1 study of Brain Neoplasms, Primary Malignant, sponsored by Jeffrey N. Bruce.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT00308165: Completed Phase 1 study of Brain Neoplasms, Primary Malignant, sponsored by Jeffrey N. Bruce.

NCT00308165 is a Phase 1 study of Brain Neoplasms, Primary Malignant that has completed, run by Jeffrey N. Bruce. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00308165, a Phase 1 study of Brain Neoplasms, Primary Malignant, has completed, sponsored by Jeffrey N. Bruce.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body. This study will also evaluate advanced magnetic resonance (MR) imaging techniques. The study will assess quality of life parameters throughout the follow-up period.

Interventions

  • DRUG Topotecan
  • PROCEDURE Convection-Enhanced Delivery

Study Locations (1)

New York

  • Columbia University Medical Center Neurological Institute - New York

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2004-03
Est. Completion 2016-01
Phase Phase 1
Jeffrey N. Bruce

2 total trials

What the finished NCT00308165 record still lists

NCT00308165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Brain Neoplasms, Primary Malignant appearing as the primary indexed condition, and to 2 interventions - of which Topotecan is the first listed.

NCT00308165 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00308165 about?

NCT00308165 is a clinical study titled "Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors". This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental ...

What is the current status of trial NCT00308165?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2004-03. Estimated completion is 2016-01.

What conditions does trial NCT00308165 study?

This clinical trial studies the following conditions: Brain Neoplasms, Primary Malignant.

What interventions are being tested in trial NCT00308165?

The interventions under investigation include: Topotecan (DRUG), Convection-Enhanced Delivery (PROCEDURE).

Who is sponsoring clinical trial NCT00308165?

This trial is sponsored by Jeffrey N. Bruce, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00308165 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00308165's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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 NCT00308165, the US trial registry maintained by the National Library of Medicine. NCT00308165 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.