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Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Jeffrey N. Bruce to Columbia Universityv13
  2. Phase: Phase 1/2 to Phase 1 Results first posted: Jun 27, 2025 · Primary completion date: Sep 2011 to Mar 2015 · Primary endpoints: 3 to 2 · 7 morev12 Show all 11 changesShow less
    • Results first posted: Jun 27, 2025
    • Primary completion date: Sep 2011 to Mar 2015
    • Primary endpoints: 3 to 2
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: 18 to 16
    • Study completion date changed from estimate of Dec 2015 to Jan 2016
    • Eligibility criteria expanded, about 285 words
    • Secondary endpoints: 1 to 2
    • Collaborators expanded, about 4 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Dec 2014 to Dec 2015v11
  4. Re-verified, no change to tracked fieldsv10
  5. Completion date: Mar 2013 to Dec 2014 Eligibility criteria expanded, about 3 words · Study description expanded, about 3 wordsv9 Show all 3 changesShow less
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Lead sponsor: Columbia University to Jeffrey N. Bruce Primary completion date: Mar 2008 to Sep 2011 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 35 to confirmed 18 · 3 morev8 Show all 7 changesShow less
    • Primary completion date: Mar 2008 to Sep 2011
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 35 to confirmed 18
    • Completion date: Mar 2013
    • Site details revised
    • Study arms: 0 to 1
  2. 3 versions Re-verified since Apr 13, 2011, no change to tracked fieldsv5-v7
  3. Phase: Phase 1 to Phase 1/2 Primary completion date: Mar 2008 · Completion date: Mar 2008 to not stated · Interventions: Convection-Enhanced Delivery (Intracerebral Clysis) (Procedure), Topotecan (Drug) to Convection-Enhanced Delivery (Procedure), Topotecan (Drug) · 1 morev4 Show all 5 changesShow less
    • Primary completion date: Mar 2008
    • Completion date: Mar 2008 to not stated
    • Interventions: Convection-Enhanced Delivery (Intracerebral Clysis) (Procedure), Topotecan (Drug) to Convection-Enhanced Delivery (Procedure), Topotecan (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
  4. Re-verified, no change to tracked fieldsv3
  5. Eligibility criteria expanded, about 1 wordv2 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00308165
Lead Sponsor Columbia University
Collaborators: National Cancer Institute (NCI)
Conditions Brain Neoplasms, Primary Malignant
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov