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Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors

NCT00308165 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-06-27

Study results available
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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.

Conditions

  • Brain Neoplasms, Primary Malignant

Interventions

PROCEDURE

Convection-Enhanced Delivery

microinfusion pumps to deliver chemotherapy directly into brain tumors

DRUG

Topotecan

chemotherapeutic drug for the treatment of brain tumors

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jeffrey N. Bruce

    lead OTHER

Principal Investigators

  • Jeffrey Bruce, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2015-03-31
Completion
2016-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00308165 on ClinicalTrials.gov