Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110032
First received: May 3, 2005
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
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)
Meningeal Melanocytoma
Drug: EF5
Procedure: conventional surgery
Procedure: positron emission tomography
Radiation: fluorine F 18 EF5
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety of F-18-EF5 based on the NCI CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Summarized in descriptive statistics.


Secondary Outcome Measures:
  • Pharmacokinetics of radioactively labeled [F-18]-EF5 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Extent of hypoxia, determined by [F-18]-EF5 PET imaging [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
  • IHC analysis of cold EF5 [ Time Frame: Up to day 1 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2005
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (fluorine F 18 EF5, PET)
Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Radiation: fluorine F 18 EF5
Given IV
Other Name: 18F-EF5
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Group 2 (EF5, PET)
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
Drug: EF5
Given IV
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Group 3 (EF5, PET)
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
Drug: EF5
Given IV
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Procedure: positron emission tomography
Undergo PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Radiation: fluorine F 18 EF5
Given IV
Other Name: 18F-EF5
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
  • Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor
  • Performance status - Karnofsky 70-100%
  • At least 3 months
  • WBC count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin < 1.2 mg/dL
  • Creatinine < 1.3 mg/dL
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No other significant cardiac condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study participation
  • Weight ≤ 130 kg
  • No peripheral neuropathy ≥ grade 3
  • No history of allergic reaction attributed to metronidazole
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No other medical condition that would preclude study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110032

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110032     History of Changes
Other Study ID Numbers: NCI-2012-02651, UPCC 01304, CDR0000423313
Study First Received: May 3, 2005
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Craniopharyngioma
Adamantinoma
Ependymoma
Glioblastoma
Glioma
Hemangiopericytoma
Medulloblastoma
Meningioma
Oligodendroglioma
Pinealoma
Choroid Plexus Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma, Subependymal
Gliosarcoma
Neoplasms, Neuroepithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014