Adult Glioblastoma Clinical Trial
Official title:
A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma
The purpose of this study is to investigate the safety and performance of an investigational agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for visualizing a tumor during surgery. It is also being studied to determine if there are differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance imaging (MRI)
PRIMARY OBJECTIVES:
I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a
glioblastoma multiforme (GBM).
II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated
on a pre-operative MRI.
SECONDARY OBJECTIVES:
I. Evaluate the time to tumor progression. II. Evaluate the overall survival.
OUTLINE:
Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.
After completion of study treatment, patients are followed up for 2 weeks.
;
| 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| Withdrawn |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 |
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 | |
| Terminated |
NCT01103375 -
Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma
|
Phase 1 | |
| Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
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 | |
| Completed |
NCT00016328 -
CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 |