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NCT01172964 · ClinicalTrials.gov registry record · Phase 1
A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas
A Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01172964 is a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma that has completed, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 43-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01172964, a Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Genetically-modified neural stem cells (NSCs) that convert 5-fluorocytosine (5-FC) into the chemotherapy agent 5-FU (fluorouracil) at sites of tumor in the brain may be an effective treatment for glioma. PURPOSE: This clinical trial studies genetically-modified NSCs and 5-FC in patients undergoing surgery for recurrent high-grade gliomas.
Conditions Studied
Interventions
- OTHER immunohistochemistry staining method
- OTHER pharmacological study
- DRUG flucytosine
- OTHER polymerase chain reaction
- BIOLOGICAL gene therapy
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-02-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01172964
The ClinicalTrials.gov registry entry for NCT01172964 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 43-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (65% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Adult Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which immunohistochemistry staining method is the first listed.
NCT01172964 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01172964 about?
NCT01172964 is a clinical study titled "A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas". RATIONALE: Genetically-modified neural stem cells (NSCs) that convert 5-fluorocytosine (5-FC) into the chemotherapy agent 5-FU (fluorouracil) at sites of tumor in the brain may be an effective treatment for glioma. PURPOSE: This clinical trial studies genetically-modified NSCs and 5-FC in patients ...
What is the current status of trial NCT01172964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-08. Estimated completion is 2015-02-11.
What conditions does trial NCT01172964 study?
This clinical trial studies the following conditions: Adult Glioblastoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor, Adult Anaplastic Astrocytoma.
What interventions are being tested in trial NCT01172964?
The interventions under investigation include: immunohistochemistry staining method (OTHER), pharmacological study (OTHER), flucytosine (DRUG), polymerase chain reaction (OTHER), gene therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01172964?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01172964 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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