Adult Anaplastic AstrocytomaPhase 1NCT00110032
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
A Phase 1 study testing EF5, conventional surgery and positron emission tomography in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
- What is being tested?
- EF5, conventional surgery and positron emission tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Central Nervous System Germ Cell Tumor, Adult Choroid Plexus Tumor
- Being tested
- EF5, conventional surgery, positron emission tomography, fluorine F 18 EF5, pharmacological study
- Medical subject headings
- Astrocytoma, Ependymoma, Oligodendroglioma, Choroid Plexus Neoplasms, Craniopharyngioma, Neuroectodermal Tumors, Primitive, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF5Drug
Given IV
conventional surgeryProcedure or surgery
Also called surgery, conventional
Undergo surgery
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo PET
fluorine F 18 EF5Radiation
Also called 18F-EF5
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (fluorine F 18 EF5, PET) | Experimental | 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. Receives: Procedure: conventional surgery; Procedure: positron emission tomography; Radiation: fluorine F 18 EF5; Other: pharmacological study |
| Group 2 (EF5, PET) | Experimental | Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning. Receives: Drug: EF5; Procedure: conventional surgery; Procedure: positron emission tomography; Other: pharmacological study |
| Group 3 (EF5, PET) | Experimental | Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. Receives: Drug: EF5; Procedure: conventional surgery; Procedure: positron emission tomography; Radiation: fluorine F 18 EF5; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Summarized in descriptive statistics.
Measured: Up to 3 years
Secondary outcomes (4)
Pharmacokinetics of radioactively labeled [F-18]-EF5
Measured: Day 1
Extent of hypoxia, determined by [F-18]-EF5 PET imaging
Measured: Up to day 1
IHC analysis of cold EF5
Measured: Up to day 1
Progression-free survival
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startJun 2005
- Primary completionJan 2007
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen Michael Hahn, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110032
- Sponsor's protocol ID
- NCI-2012-02651
- Other IDs
- UPCC 01304, CDR0000423313
- Status last verified
- Jan 2013
- First submitted
- 3 May 2005
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00110032
- Acronym / sponsor ID
- NCI-2012-02651
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Central Nervous System Germ Cell Tumor, Adult Choroid Plexus Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2005
- Primary completion
- Jan 2007 (actual)
- First posted
- 4 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (fluorine F 18 EF5, PET) | Experimental | Procedure: conventional surgery, Procedure: positron emission tomography, Radiation: fluorine F 18 EF5, Other: pharmacological studyPatients 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. |
| Group 2 (EF5, PET) | Experimental | Drug: EF5, Procedure: conventional surgery, Procedure: positron emission tomography, Other: pharmacological studyPatients 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 (EF5, PET) | Experimental | Drug: EF5, Procedure: conventional surgery, Procedure: positron emission tomography, Radiation: fluorine F 18 EF5, Other: pharmacological studyPatients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EF5Given IV | Drug | Group 2 (EF5, PET), Group 3 (EF5, PET) |
| conventional surgeryAlso: surgery, conventionalUndergo surgery | Procedure or surgery | Group 1 (fluorine F 18 EF5, PET), Group 2 (EF5, PET), Group 3 (EF5, PET) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo PET | Procedure or surgery | Group 1 (fluorine F 18 EF5, PET), Group 2 (EF5, PET), Group 3 (EF5, PET) |
| fluorine F 18 EF5Also: 18F-EF5Given IV | Radiation | Group 1 (fluorine F 18 EF5, PET), Group 3 (EF5, PET) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Group 1 (fluorine F 18 EF5, PET), Group 2 (EF5, PET), Group 3 (EF5, PET) |
Primary outcome
Safety of F-18-EF5 based on the NCI CTCAE version 3.0
Time frame: Up to 3 years
Summarized in descriptive statistics.
4 secondary outcomes
Pharmacokinetics of radioactively labeled [F-18]-EF5
Time frame: Day 1
Extent of hypoxia, determined by [F-18]-EF5 PET imaging
Time frame: Up to day 1
IHC analysis of cold EF5
Time frame: Up to day 1
Progression-free survival
Time frame: Up to 6 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Michael Hahn principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EF5, conventional surgery and positron emission tomography in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of F-18-EF5 based on the NCI CTCAE version 3.0 (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.