Adult Glioblastoma Clinical Trial
Official title:
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
undergoing surgery for recurrent high-grade gliomas.
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of intracerebral administration of NSCs in
combination with oral 5-FC in patients with recurrent high-grade gliomas.
SECONDARY OBJECTIVES:
I. To characterize the relationship between intracerebral and systemic concentrations of 5-FC
and 5-FU with increasing NSC dose level.
II. To non-invasively assess the presence of 5-FU in the brain with the use of fluorine
(19F)-magnetic resonance spectroscopy (MRS)(no longer in effect as of 5/1/2012).
III. To assess for the possible development of immunogenicity against the NSCs.
IV. To assess the intracerebral distribution of NSCs using iron-labeling as a cellular
tracker.
V. To gather preliminary imaging data regarding perfusion permeability parameters and imaging
characteristics as shown on magnetic resonance imaging (MRI) studies due to the presence of
NSCs in the brain.
VI. To determine, at time of autopsy, the fate of the NSCs.
OUTLINE:
This is a dose-escalation study.
After biopsy or surgery to resect tumor, study patients receive injections of genetically
modified NSCs directly into brain tissue on day 0. Patients then take oral 5-FC every 6 hours
during days 4-10 which is converted to 5-FU in the brain by the NSCs.
Follow-up MRIs of the brain are performed on days 32, 60, and every 2 months thereafter to
assess for response and side effects.
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