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NCT00031083 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas
A Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 5
- Study locations
NCT00031083 is a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma that has completed, run by Biogen. The registered enrollment target is 12 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (88% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT00031083, a Phase 1 study of Glioblastoma Multiforme and Gliosarcoma, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 5
- Study locations
Study Summary
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis
Conditions Studied
Interventions
- GENETIC Interferon-beta
Study Locations (5)
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- University of Arizona at Tucson - Tucson
Colorado
- University of Colorado Health Sciences Center - Denver
Massachusetts
- Massachusetts General Hospital - Boston
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2002-04-02 |
| Est. Completion | 2003-10-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031083
The ClinicalTrials.gov registry entry for NCT00031083 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (88% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Interferon-beta is the first listed.
NCT00031083 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT00031083 about?
NCT00031083 is a clinical study titled "Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas". In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evalua...
What is the current status of trial NCT00031083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2002-04-02. Estimated completion is 2003-10-10.
What conditions does trial NCT00031083 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma, Oligoastrocytoma, Mixed.
What interventions are being tested in trial NCT00031083?
The interventions under investigation include: Interferon-beta (GENETIC).
Who is sponsoring clinical trial NCT00031083?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00031083 being conducted?
This trial has 5 study locations across Alabama, Arizona, Colorado, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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