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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

Primary Purpose

Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EF5
conventional surgery
positron emission tomography
fluorine F 18 EF5
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 (fluorine F 18 EF5, PET)

Group 2 (EF5, PET)

Group 3 (EF5, PET)

Arm Description

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.

Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.

Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.

Outcomes

Primary Outcome Measures

Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Summarized in descriptive statistics.

Secondary Outcome Measures

Pharmacokinetics of radioactively labeled [F-18]-EF5
Extent of hypoxia, determined by [F-18]-EF5 PET imaging
IHC analysis of cold EF5
Progression-free survival

Full Information

First Posted
May 3, 2005
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00110032
Brief Title
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
Official Title
Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (fluorine F 18 EF5, PET)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (EF5, PET)
Arm Type
Experimental
Arm Description
Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
Arm Title
Group 3 (EF5, PET)
Arm Type
Experimental
Arm Description
Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.
Intervention Type
Drug
Intervention Name(s)
EF5
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
surgery, conventional
Intervention Description
Undergo surgery
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo PET
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 EF5
Other Intervention Name(s)
18F-EF5
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Description
Summarized in descriptive statistics.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Pharmacokinetics of radioactively labeled [F-18]-EF5
Time Frame
Day 1
Title
Extent of hypoxia, determined by [F-18]-EF5 PET imaging
Time Frame
Up to day 1
Title
IHC analysis of cold EF5
Time Frame
Up to day 1
Title
Progression-free survival
Time Frame
Up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Michael Hahn
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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