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NCT00088400 · ClinicalTrials.gov registry record · Phase 3
Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors
A Phase 3 study of Glioblastoma, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00088400 is a Phase 3 study of Glioblastoma that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00088400, a Phase 3 study of Glioblastoma, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Objectives: Primary Objective: To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. Secondary Objectives: To assess the safety of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. To evaluate possible differences in efficacy and/or safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels. Study Design: Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas, platinum compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) \& vincristine). A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed.
Conditions Studied
Interventions
- DRUG TransMID
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088400
The ClinicalTrials.gov registry entry for NCT00088400 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (72% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which TransMID is the first listed.
NCT00088400 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00088400 about?
NCT00088400 is a clinical study titled "Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors". Study Objectives: Primary Objective: To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. Secondary Objectives: To assess the safety of intratumoral/int...
What is the current status of trial NCT00088400?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2004-07. Estimated completion is 2005-11.
What conditions does trial NCT00088400 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT00088400?
The interventions under investigation include: TransMID (DRUG).
Who is sponsoring clinical trial NCT00088400?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088400 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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