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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: Completed Phase 1 study of Adult Glioblastoma and Adult Giant Cell Glioblastoma, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measures of feasibility include the incidence of clinically symptomatic intratumoral hemorrhage, CNS infection, seizures, altered mental status, development of focal neurologic deficits, as well as chemotherapy-associated toxicities. All toxicities at each dose level will be summarized using descriptive statistics. Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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 |
What the finished NCT01172964 record still lists
NCT01172964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 43-participant average among 14 other Adult Glioblastoma trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Adult Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01172964's enrollment target sits among peer trials
15 13th of 14 higher than 2 of 14 other Adult Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
COMPLETED · Phase 1
-
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
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