drugset / Trial / NCT01172964

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

NCT01172964

Phase 1 Completed 15 enrolled City of Hope Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2015-02-11
Completion
2015-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject E. coli CD-expressing genetically modified neural stem cells Cell therapy Other
Subject Flucytosine Small molecule Oral