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

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

• 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

DRUG

flucytosine

Given orally

OTHER

polymerase chain reaction

Correlative studies

OTHER

immunohistochemistry staining method

Correlative studies

BIOLOGICAL

gene therapy

Injected at the time of the surgery to resect the tumor

OTHER

pharmacological study

Correlative studies

OTHER

3-Tesla magnetic resonance imaging

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

PROCEDURE

therapeutic conventional surgery

Surgery to resect the tumor

BIOLOGICAL

E. coli CD-expressing genetically modified neural stem cells

Injected at the time of the surgery to resect the tumor

Sponsors & Collaborators

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Jana Portnow · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2015-02-11

Completion

2015-02-11

Countries

• United States

Study Locations