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(19F)-magnetic resonance spectroscopy (MRS)(no longer in effect as of 5/1/2012).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.
;
| 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| Withdrawn |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 |