Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Brain Stem Glioma
  • Adult Central Nervous System Germ Cell Tumor
  • Adult Choroid Plexus Tumor
  • Adult Craniopharyngioma
  • Adult Diffuse Astrocytoma
  • Adult Ependymoblastoma
  • Adult Ependymoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Grade I Meningioma
  • Adult Grade II Meningioma
  • Adult Grade III Meningioma
  • Adult Medulloblastoma
  • Adult Meningeal Hemangiopericytoma
  • Adult Mixed Glioma
  • Adult Myxopapillary Ependymoma
  • Adult Oligodendroglioma
  • Adult Pilocytic Astrocytoma
  • Adult Pineoblastoma
  • Adult Pineocytoma
  • Adult Subependymoma
  • Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
  • Astrocytoma
  • Choroid Plexus Neoplasms
  • Craniopharyngioma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Gliosarcoma
  • Hemangiopericytoma
  • Medulloblastoma
  • Meningeal Melanocytoma
  • Meningioma
  • Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Oligodendroglioma
  • Solitary Fibrous Tumors

NCT number NCT00110032
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 1
Start date June 2005

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 NCT00049387 - Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma Phase 1
Completed NCT02227901 - Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme 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