Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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assess the presence of 5-FU in the brain with the use of fluorine (19F)-magnetic resonance spectroscopy (MRS)(no longer in effect as of 5/1/2012).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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01172964
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 1
Start date August 2010
Completion date February 11, 2015

See also
  Status Clinical Trial Phase
Terminated NCT02530502 - Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma Phase 1
Withdrawn NCT02194452 - Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors N/A
Completed NCT00238303 - Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme Phase 2
Completed NCT02227901 - Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Phase 1
Completed NCT00049387 - Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Phase 1
Completed NCT02015819 - Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas Phase 1
Active, not recruiting NCT02179086 - Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Phase 2
Recruiting NCT04573140 - A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM) Phase 1
Active, not recruiting NCT00823797 - Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma Phase 2
Completed NCT00045565 - Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma Phase 1
Completed NCT01977677 - Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma Phase 1/Phase 2
Completed NCT01648348 - Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00004262 - Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme Phase 1
Terminated NCT01575275 - Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme Phase 2
Terminated NCT01996527 - 3T MRI Biomarkers of Glioma Treatment Response Early Phase 1
Completed NCT01119599 - RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma Phase 1
Completed NCT01131234 - Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01103375 - Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma Phase 1
Completed NCT00459381 - Pazopanib in Treating Patients With Recurrent Glioblastoma Phase 2
Completed NCT00316849 - Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Phase 1