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
Public ClinicalTrials.gov record NCT01172964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01172964
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
- Adult Anaplastic Astrocytoma
- Recurrent Grade III Glioma
- Recurrent Grade IV Glioma
- Adult Anaplastic Oligodendroglioma
- Adult Brain Tumor
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Adult Mixed Glioma
- Recurrent Adult Brain Tumor
- Adult Anaplastic Oligoastrocytoma
- Recurrent High Grade Glioma
Interventions
- flucytosine Drug
- polymerase chain reaction Other
- immunohistochemistry staining method Other
- gene therapy Biological
- pharmacological study Other
- 3-Tesla magnetic resonance imaging Other
- laboratory biomarker analysis Other
- therapeutic conventional surgery Procedure
- E. coli CD-expressing genetically modified neural stem cells Biological
Drug · Other · Biological + 1 more
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2010
- Primary completion
- Feb 10, 2015
- Completion
- Feb 10, 2015
- Last update posted
- Nov 8, 2017
2010 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01172964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 8, 2017 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01172964 live on ClinicalTrials.gov.