At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 16 enrolled

Drug / intervention

Topotecan +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00308165

NCT00308165Phase 1Completed

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A Phase I Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors

Columbia University·interventional·Posted Mar 29, 2006·Updated Jun 25, 2026

In Brief

A Phase 1 clinical trial evaluating Convection-Enhanced Delivery and Topotecan for Brain Neoplasms, Primary Malignant. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBrain Neoplasms, Primary Malignant

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2004

First PostedMar 2006

Primary CompletionMar 2015

Study CompletionJan 2016

TodayJul 2026

First PostedMar 29, 2006

Enrollment StartMar 1, 2004

Primary CompletionMar 1, 2015

Study CompletionJan 1, 2016

TodayJul 2, 2026

Enrollment to primary: 11 yearsPosted 20.3 years ago

Interventions

Convection-Enhanced Deliveryprocedure

microinfusion pumps to deliver chemotherapy directly into brain tumors

Topotecandrug

chemotherapeutic drug for the treatment of brain tumors