Adult Glioblastoma Clinical Trial
Official title:
Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
PRIMARY OBJECTIVES:
I. Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed
brain tumors undergoing surgery or biopsy.
Secondary I. Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered
before and after nonradioactive EF5 in these patients.
II. Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to
detect tumor hypoxia in these patients.
III. Determine the presence and pattern of nonradioactive EF5 binding by
immunohistochemistry (IHC) and/or flow cytometry in these patients.
IV. Correlate tumor hypoxia, as measured by PET scanning using ^18F-EF5, with EF5 staining
by IHC and/or flow cytometry and recurrence-free survival of these patients.
OUTLINE: Patients are assigned to 1 of 3 groups.
Group 1: Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole
body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients
then receive nonradioactive EF5 IV over 1-2 ½ hours.
Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV.
Patients then undergo whole brain and whole body PET scanning.
Group 3: Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then
undergo whole brain PET scanning. Approximately one day after EF5 administration, all
patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the
incision.
Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3
months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually
thereafter.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| 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 |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
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 |
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 |